FDA Adverse Event Death Summary report: N

FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

MDR report key: 547542 · Received October 1, 2004

Report

Report Number
6000001-2004-01506
Event Type
Death
Date Received
October 1, 2004
Date of Event
August 16, 2004
Report Date
September 3, 2004
Manufacturer
BAXTER HEALTHCARE PTE. LTD.
Product Code
FRN
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
NJ, US
Reporter Occupation
BIOMEDICAL ENGINEER

Narratives

Description of Event or Problem · 1

THE FACILITY'S BIOMED REPORTED THE PUMP FREE-FLOWED DURING CLINICAL USE AND EXPIRED SEVERAL DAYS FOLLOWING THE INCIDENT. THE PT WAS UNDERGOING SURGICAL REPAIR OF AN ABDOMINAL AORTIC ANEURYSM (AAA) IN 2004. PRIOR TO THE SURGERY THE PT WAS DESCRIBED AS "WALKING AND TALKING". THE SURGERY WAS DESCRIBED AS SUCCESSFUL AND THE PT AROUSABLE AND EXTUBATED IN THE RECOVERY ROOM (PACU). AFTER THE SURGERY THE PT HAD A MOREPHINE EPIDURAL, WENT TO RECOVERY AND WAS EXTUBATED. IV FLUID D5.45 NORMAL SALINE WAS BEING INFUSED AT 110 CC/HR PRE A TRIPLE LUMEN CATHETER. AT APPROX 8:00PM THE PT BECAME AGITATED PER THE CHART AND AT 8:30PM DIPRIVAN DRIP WAS STARTED AT A RATE OF 15CC/HR AND PLACED ON FLO-GARD PUMP BY THE ANESTHESIOLOGIST. AT 9:15PM THE DIPIVAN WAS DECREASED TO A RATE OF 12CC/HR AND PER THE CHART THE PT'S VITAL SIGNS WERE STABLE IN RECOVERY. THE PT WAS THEN TRANSFERRED TO ICU IN "GOOD CONDITION" ON AN EKG MONITOR, NO OXIMETER AND ONE FLOW-GARD IV PUMP. THE PT ARRIVED IN THE ICU AT 10:09PM. THE KEG MONITOR WAS TAKEN OFF DURING TRANSFER OF PT FROM CART TO BED. IV TAKEN OFF PUMP DURING PT TRANSFER TO GAIN SLACK IN TUBING. AFTER REMOVAL OF EKG MONITOR AND IV PUMP, PT TRANSFERRED TO BED, ICU RN REMOVED EXTRA LINEN, AND PERFORMED PT ASSESSMENT. RN ATTEMPTED PEDAL PULSE ASSESSMENT BY DOPPLER. RN UNABLE TO OBTAIN NECK PULSE. PT PLACED BACK ON MONITOR. FIRST RHYTHM INTERPRETED AS COMPLETE HEART BLOCK (CHB) (NOT DEFINITIVE AS LENGTH OF STRIP INSUFFICIENT), FOLLOWED BY VFIB AND ASYSTOLE. BAXTER HAS RECEIVED VARYING REPORTS FROM THE FACILITY ON THE AMOUNT OF DIPRIVAN REMAINING IN BOTTLE AND THE IV SAFETY CLAMP POSITION AT TIME OF ARRIVAL TO ICU. THE FIRST ICU NURSE REPORTS DIPRIVAN WAS NOT ON THE IV PUMP UPON PT ARRIVAL TO ICU, OTHER RNS STATED DIPRIVAN WAS ON THE PUMP. ONLY ONE PUMP WAS IN USE AT THE TIME OF TRANSPORT. ONE RECOVERY NURSE STATES IV REMOVED FROM PUMP, SAFETY CLAMP ENGAGED, BOTTLE THEN NOTED TO BE EMPTY AND REQUEST MADE FOR A NEW BOTTLE. AT 10:28PM CODE CALLED, LASTED 11 MINUTES PER CHART AND THE PT WAS RESUSCITATED. 14 DAYS LATER THE PT NEVER REGAINED CONSCIOUSNESS AND EXPIRED. THE EXACT CAUSE OF DEATH IS NOT KNOWN AT THIS TIME SINCE NO AUTOPSY WAS PERFORMED AND RESULTS OF THE TOXICOLOGY EXAM RESULTED IN A RESULT OF QUANTITY OF BLOOD DRAWN NOT SUFFICIENT TO MAKE DETERMINATION. THERE WERE 2 FLO-GARD 6201 PUMPS REPORTED TO BAXTER AS POTENTIALLY HAVING BEEN INVOLVED IN THIS REPORT, HOWEVER, THE EXACT PUMP INVOLVED IS NOT CLEAR. THE LAST PROGRAMMING INFO THAT WAS PULLED FROM PUMP WAS 12CC/HR, WHICH IS WHAT THE PUMP INVOLVED IN THIS INCIDENT WAS REPORTED TO BE LAST PROGRAMMED AT, BUT PUMP DID NOT HAVE ANY PREVIOUS PROGRAMMING INFO SAVED SO BOTH PUMPS ARE BEING TREATED AS SUSPECT AT THIS POINT. REFERENCE MDR 6000001-2004-01504.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 FLO-GARD 6201 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. 6201 NA

Patients

Seq Age Sex Outcome Treatment
1 66 YR Death PHARMACEUTICALS FOR BAXTER, LOT# 04D336, THERAPY| DIPRIVAN (MANUFACTURED BY GENSIASICOR| DATES UNK). 2C6537- CONTINU-FLO SOLUTION SET (LOT#| AND THERAPY DATES UNK).