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News: Following successful shoulder surgery, a patient was inadvertently overdosed with Demerol via a malfunctioning anesthesia pump. She was found unresponsive more than an hour later. Although she was revived, she has residual cognitive deficits, clinical depression, and post-traumatic stress disorder symptoms. A jury awarded her $350,000 in the claim against the hospital. Her case against the pump manufacturer was settled confidentially.
Background: A 34-year-old licensed practical nurse (LPN) was admitted to the hospital for minor shoulder surgery. During the post-surgery recovery period, she was placed on a Baxter PCA II anesthesia pump, a patient-controlled device for delivering medications. If the pump had operated properly, the patient would have received doses of pain medication within safe parameters. However, the Baxter PCA II unit used by the plaintiff was coupled with a Baxter model 3507 extension set, which did not incorporate an anti-siphon valve. As a result, over a period of 82 minutes, the patient was given approximately 5 cm3 of Demerol — an overdose.
The plaintiff alleged that the hypoxic event resulted in mild damage, leaving her incapable of experiencing a full range of emotional responses and decreasing her IQ to a level where she is no longer able to function safely as an LPN.
The plaintiff alleged that if the hospital had used the Baxter PCA II pump with the appropriate extension set — one with an anti-siphon valve, costing about 40 cents per set, her injuries would have been prevented. The plaintiff also maintained that nurses incorrectly placed the syringe into the pump, allowing too much Demerol to be released.
In the case against the manufacturer, the plaintiff claimed that it was negligent for Baxter Healthcare to have manufactured and sold extension-set products that did not use an anti-siphon valve feature. The manufacturer entered into a confidential settlement agreement with the plaintiff approximately five months prior to trial.
The defendant hospital argued that Baxter Healthcare was 100% responsible and designated the manufacturer as a nonparty. The hospital denied it was negligent for failing to use extension sets incorporating the anti-siphon valve, arguing that they used the extension set that had been recommended by Baxter Healthcare. The defendant hospital went on to say that the plaintiff did not sustain any organic brain damage and that her current problems were actually caused by depression, a treatable condition.
At trial, the defendant’s expert testified that the plaintiff could return to work as an LPN after approximately two months of appropriate mental health therapy. The hospital also denied that its nurses were negligent in the positioning of the syringe into the Baxter PCA II.
The jury returned a verdict in favor of the plaintiff and awarded $350,000 ($33,000 for medical and related health care expenses, $76,000 for past lost earnings, $200,000 for post-noneconomic damages, and $41,000 for future medical expenses).
What this means to you: "This case raises a number of issues regarding the purchase, maintenance, usage, and updating of equipment used by a hospital in its operating suites, as well as in recovery and/or post-op rooms. It also raises questions relative to the monitoring of patients in post-op by nursing staff, including charting of this information by staff. There could also be some potential issues relative to the application of occurrence/incident reports in the hospital, review or investigation by risk managers of adverse events, and appropriate use of quality improvement/peer review process for enhancement of patient safety and reduction of adverse events. Additionally, this is the type of incident that could lend itself to a root-cause analysis since it appears that there could have been a breakdown in several important processes or systems within the hospital," observes R. Stephen Trosty, JD, MHA, HRM, director, Risk Management Consulting, American Physicians Assurance Corp. in East Lansing, MI.
"Specifically, one would first want to look into what the facility’s contract was with the equipment manufacturer or vendor to see if the agreement included a hold-harmless clause," notes Trosty. "Generally, risk management should be involved in a hospital’s contract review processes so that potential risk management issues may either be addressed directly in such contracts or so that the potential for repercussions can be accessed. Seemingly, there was not a hold-harmless clause; otherwise, once the case against the manufacturer was settled, this claim would have presumably been dropped. Accordingly, the risk manager in this instance should have been aware that the liability for any adverse incidents involving the use of the pump would reside with the hospital."
"Once the risk manager realizes that the facility is potentially liable for the equipment, specific protocols regarding the use of the anesthesia pump should be implemented. Actually, at a minimum, all equipment throughout a facility should be assessed prior to being used on patients. Policies and procedures should be in place to provide for initial and regular maintenance and review of all equipment employed. For instance, with equipment such as the anesthesia pump one might recommend that an equipment log be instituted. A standard usage log should include parameters such as: a) providing general instructions regarding proper use of the equipment as well as note appropriate and inappropriate attachments or extensions; b) indicating when the equipment is used so that a standard maintenance and replacement schedule can be established; and c) offering the opportunity to note any problems with the pump so that they can be appropriately addressed or at least known before the equipment is used again," adds Trosty.
"Additionally, when equipment is first purchased it should be tested and evaluated. Anesthe-sia pumps are widely used and accepted as customary for patients recovering from surgery, and so one wonders who at the hospital was responsible for regularly checking and assessing equipment that is routinely and regularly utilized. In this case, one questioned whether or not the facility initially evaluated the anesthesia pump to see whether it should have been independently upgraded by adding an anti-siphon value instead of depending upon the existing valve. Presumably, someone at the hospital should have been responsible for maximizing the effectiveness and efficacy of equipment to best address patient safety concerns particularly when equipment is often used. And if the pump was initially evaluated and an anti-siphon valve was not included at that time, personnel responsible for equipment oversight might be questioned as to whether or not the manufacturer issued information on the equipment suggesting that an upgrade was recommended, necessary, or required. Given the fact that the manufacturer settled prior to the case going to trial, it seems that they arguably did have some duty to supply such information and provide purchasers with data on more effective and safer use of their equipment. Further, once the pump was known to have malfunctioned, it is not clear who had the responsibility for assessing and correcting the situation and whether the specific pump was immediately sequestered and independently analyzed as should have occurred. Essentially, the key question and bottom line is why the anesthesia pump was being used with an extension set that did not have a fail-safe anti-siphon valve, particularly in light of the minimal cost involved with the seemingly simple upgrade," Trosty says.
"The equipment purchasing, assessment, and evaluation questions aside, this case raises questions as to whose responsibility it was to handle and address the consequences of an equipment malfunction. What tests were performed on the patient, if any, to determine extent of her damages after she was found nonresponsive? And, specifically, were any tests performed to determine if the patient sustained any organic brain damage? If such tests were not performed, the risk manager would need to determine why they were not done. Given that the patient was found nonresponsive, she should have been assessed and tested to determine the extent of her injuries, if any, so that she could have been properly treated and cared for following the incident," notes Trosty.
"As for the hospital’s nursing staff the following questions come to mind: What was done to determine the positioning of syringe by the nurse? Was there a notation of syringe placement in the chart? Was any notice taken of the placement after the patient was found nonresponsive? What was the training of the nursing staff relative to placement? Was there documentation of training of the nurse involved in the case relative to syringe placement? Was there any evidence that the nurse ever placed a syringe in a manner alleged by the plaintiff to have been incorrect or any evidence that this allegedly incorrect type of placement was routinely used by the hospital or nursing staff? Finally, was there any evidence that the placement of the syringe as it relates to type of extension set used in this case was or was not an issue in caring for this patient?" questions Trosty.
"Further, as to the nursing care, additional questions are raised relative to the risk manager’s role in the matter. Was an occurrence report completed? If not, why not? Obviously, once a patient is determined to be nonresponsive and the apparent source is pain medication overdose due to equipment malfunction, an adverse incident report should have been issued. Once such report is issued, it should be the hospital risk manager’s duty to conduct an investigation. And, if a report was not issued, the lack thereof should be investigated. Alternatively, if such a report was submitted, were any of the issues raised in this discussion looked at by the risk manager and was any relevant evidence collected during the investigation that could have responded to the allegations? If not, the root causes of the oversight should be examined whether it was because the risk manager overlooked it or because the risk manager could not obtain necessary information. Further, was this occurrence reviewed as part of the facility’s quality improvement and/or peer review processes? If not, why not? The hospital and staff should attempt to review existing systems, policies, procedures, equipment usage and upgrading as well as staff training and education to determine what could be learned from this occurrence so that it would not happen again," observes Trosty.
"Specifically as to the post-operative nursing care, one wonders whether the patient was monitored during the 82 minutes following surgery. And, if in fact she was monitored, what was the patient checked for and was any of this post-surgery care charted? This includes questions regarding how often the patient was checked, conversely how often should she have been observed, whether or not the flow of Demerol was assessed as part of the routine post-operative care, and even whether her vital signs were taken, given that when she finally was found she was unresponsive at that point. Further, if the patient was not adequately monitored, the causes of that failure should be examined — was it due to overcrowding in the recovery room, was there an adequate number of staff, and was the staff present adequately trained in post-operative care?" asks Trosty.
"This case leaves many questions about the facility’s routine equipment maintenance and operation as well as post-operative nursing care and general risk management practices. In retrospect, it is probably fortunate that the outcome was not even more significant given the basic malfunction of the anesthesia pump and seeming lack of hospital systems to have appropriately addressed the situation," concludes Trosty.