The device is not available for evaluation, therefore, a comprehensive investigation cannot be performed.If additional information becomes available, a supplemental report will be submitted.
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The customer reported that a plum a+ was set to run at 28mls but at approximately, 13:30, the nurse and co-signing nurse observed that the 28 ml step was running incorrectly at 76.3 mls.It is unknown how long the device was overinfusing at 76.3 ml.The rate was returned to 28 ml.There was patient involvement but no harm was reported.
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Additional information was received that stated that the patient had a peripherally inserted central catheter (picc) in the left forearm and due to total parenteral nutrition (tpn) going on up late and changing bch bag upon admission on (b)(6) 2020, tpn break reduced from 4 hours to 1 hour (14:30 ¿15:30).Order amended after tpn bag hung and running.At 12:30, the nurse had reviewed the pump to ensure settings matched with new order and confirmed they were correct.At approximately 13:30, it was observed that the 28 ml step was incorrectly running at 76.3 mls.It was unclear how long the 76.3 ml step had been running.The rate was returned to 28 mls per hour.The plan was reported to let steps progress as ordered and check point of care (poc) blood glucose at end of infusion.At approximately 14:00, patient became tachycardic into 200s and was extremely sweaty.Point of care glucose = 36, the patient was evaluated, and 0.1 mg glucagon was administered with a positive effect.Repeat blood glucose =100.Tpn cycled down again, titrated at 28 and 14 mls for ½ hour each.Prn lasix 7 mg administered due to increased iv fluid.New tpn hung at 3:30 starting at 14 mls per hour as ordered.Peripheral labs obtained at 16:00, comprehensive metabolic panel and venous blood glucose values were within normal limits.The patient was monitored for additional signs and symptoms of hypoglycemia.Iv pump was replaced and a new pump was used to start a new tpn infusion.It is not evident that the harm was a life-threatening event or that an intervention was required to preclude permanent impairment of a body function or permanent damage to a body structure.In addition, the customer stating that the device was inspected at the user facility and no defects/damage was found.Full functional test was performed and all parameters passed successfully.Occlusion, proximal/distal alarms passed and volume delivery was accurate.
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