FDA Adverse Event Malfunction Summary report: N

SYMBIQ PUMP

MDR report key: 1760765 · Received July 13, 2010

Report

Report Number
MW5016734
Event Type
Malfunction
Date Received
July 13, 2010
Date of Event
July 11, 2010
Report Date
July 13, 2010
Manufacturer
SYMBIQ
Product Code
FRN
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
AL, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

MULTIPLE RNS WERE AT BEDSIDE PERFORMING PT CARE WHEN THE SYMBIQ PUMP EMITTED A HIGH-PITCHED ALARM CALLING ATTENTION TO A WHITE SCREEN WITH AN ERROR MESSAGE THAT QUICKLY DISAPPEARED. THE PUMP THEN LOCKED THE RNS OUT, AND DID NOT ALLOW FOR REMOVAL OF THE TUBING/CASSETTE. THE PT HAPPENED TO BE A NEWLY ADMITTED BURN PT WHO WAS GREATER THAN 70% TBSA. HE WAS STILL IN THE EARLY HOURS OF FLUID RESUSCITATION AND HAD 1800ML/HR OF LACTATED RINGERS BEING DELIVERED THROUGH THIS PUMP THAT HAD FAILED AND SHUT DOWN WITHOUT ANY PRIOR WARNING. EXTRA PUMPS WERE STANDING BY IN THE PT'S ROOM AND NEW LINES WERE QUICKLY PRIMED AND CONNECTED TO THE PT. WHILE THESE NEW LINES WERE BEING PRIMED, AND THE NEW PUMP WAS BEING PROGRAMMED -APPROX 5 MINUTES TRANSPIRED-, THE VASOPRESSOR THAT WAS CURRENTLY RUNNING -FROM A SEPARATE PUMP- TO ASSIST THE PT IN MAINTAINING A MAP GREATER THAN 70 MMHG HAD TO BE INCREASED FROM 0.02MCG/KG/MIN TO 0.06MCG/KG/MIN. THE PT'S MAP DROPPED TO 68MMHG BEFORE THE INCREASE TO THE VASOPRESSOR RATE TOOK EFFECT. THE MAP QUICKLY RECOVERED AND NO SIGNIFICANT INJURY WAS APPRECIATED. TREATMENT CONTINUED FROM THERE. THE PUMP IN QUESTION WAS RED-TAGGED AND PROMPTLY DELIVERED TO THE ROTATING HILL-ROM ATTENDANT ON DUTY. THE ATTENDANT WAS NOTIFIED OF THE PROBLEM, AND STATED THAT HE WOULD NOT ONLY DELIVER THE PUMP TO BIOMED, BUT WOULD ALSO DELIVER A SUMMARY OF THE EVENT THAT HAD TRANSPIRED. AN EMAIL WAS COMPOSED AND SENT TO NURSE MANAGER REQUESTING THAT PTS REQUIRING VASOPRESSORS AND HIGH FLUID VOLUMES BE PROVIDED WITH THE PREVIOUSLY IMPLEMENTED PUMPS PRIOR TO THOSE BEING USED CURRENTLY -BECAUSE EVENTS SUCH AS THESE WERE NOT KNOWN TO OCCUR WITH THE PREVIOUS PUMPS-.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SYMBIQ PUMP PUMP FRN SYMBIQ UNK

Patients

Seq Age Sex Outcome Treatment
1 42 YR