ABVISER-INTRA ABDOMINAL PRESSURE MONITOR DEVI

Description of Event or Problem

PT WAS ADMITTED FOR HEPATECTOMY (LIVER REMOVAL). DURING SURGERY OCCURRED BLOOD LOSS AND THE PT UNDERWENT VOLEMIC RESUSCITATION AND REMAINED HOSPITALIZED IN THE INTENSIVE CARE UNIT, AND THEN USED ADVISER. PT EXPERIENCED URINE RETENTION IN BLADDER. CURRENTLY THE PT IS SEDATED, IS BEING ADMINISTERED INTRAVENOUS NORADRENALINE, IS BREATHING WITH O2 SUPPORT BY MECHANICAL VENTILATION. ADD'L INFO WAS REC'D FROM THE COMPLAINT ORIGINATOR. THE PT WAS SEDATED. ONLY ONE MEASURE WAS TAKEN AND 20 ML WAS INSTILLED. THE VITAL SIGNS OF THE PT WERE MONITORED EVERY 2 HRS. THE USE OF THE DEVICE WAS INITIATED ON (B)(6) AROUND 11:00 AM AND THE PROBLEM NOTICED ON THE SAME DATE, DURING THE NIGHT. THE DEVICE WAS REMOVED ON (B)(6), AT SOME POINT BEFORE 11:00 AM. AFTER REMOVAL, THE DEVICE WAS DISCARDED. THE DOCTOR ISN'T COOPERATING AS MUCH AS NEEDED AND THE HOSPITAL CLAIMS NOT TO FIND THE PT'S CHART. ADD'L REQUESTS TO THE HOSPITAL HAVE BEEN MADE BUT HAVE BEEN UNSUCCESSFUL.

Additional Manufacturer Narrative

THE COMPLAINT STATED THAT THE DEVICE MALFUNCTION RESULTED IN THE RETENTION OF 1.5 L OF URINE IN THE PT'S BLADDER. THIS WOULD HAVE PROMPTED A MEDICAL INTERVENTION TO PREVENT SOME MORE SERIOUS CONSEQUENCES FOR THE PT. (B)(4).