BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMED PUMP

    MDR report key: 179535 · Received July 27, 1998

    Report

    Report Number
    MW1014253
    Event Type
    Malfunction
    Date Received
    July 27, 1998
    Date of Event
    July 8, 1998
    Report Date
    July 14, 1998
    Manufacturer
    ALARIS MEDICAL SYSTEMS INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ORHS WAS EXPERIENCING MAJOR DIFFICULTIES WITH BOTH 1CH, 2CH AND 4CH IMED PUMPS. CRITICAL AREAS WITHIN ORHS REQUIRED IMMEDIATE SERVICING. ALARIS HAD BEEN CONTACTED BY NUMEROUS SMDA'S REPORTING MALFUNCTIONING OF IMED PUMPS WITHIN ORHS. ALARIS RESPONDED WITH THEIR CONTRACTED REP FROM PHYSIO CONTROL. INITIALLY THE IMED PUMPS WERE THOUGHT TO BE SOLELY A BATTERY PROBLEM. ALL BATTERIES WERE CHANGED OUT, HOWEVER THE MALFUNCTIONING PERSISTED. BIOMED AND ALARIS/PHYSIO REACHED THE CONCLUSION THAT THE MACSWITCHES IN ALL THE PUMPS REQUIRED CHANGING OUT. IT BECAME APPARENT THAT THE MACSWITCHES WERE BEING REPLACED AS ROUTINE MAINTENANCE'S WERE BEING COMPLETED ON THE MACHINES. THESE REPLACEMENTS WERE DUE TO THE DISCOVERY OF THE CORRODED PLATES IN THE ORIGINAL DESIGN. (ALARIS HAD REDESIGNED THE SWITCHES TO AVOID FUTURE CORROSION TAKING PLACE). MAJORITY OF ORHS SWITCHES HAD NOT BEEN CHANGED. ALARIS SENT TO ORHS A TEAM TO SWITCH OUT THE MACSWITCHES ALONG WITH AN ADDITIONAL THIRTY (30) NEW PUMPS TO EXCHANGE THE FAULTY PUMPS IN THE CRITICAL AREAS. IN ADDITION TO THIS ALARIS SENT ALONG A VIDEO FOR IN-SERVICING. AS OF SEPTEMBER 28TH, 75% OF THE PUMPS HAD BEEN CHANGED OUT. ORHS APPRECIATES ALARIS AND THE RESPONSE AND IMMEDIATE ATTENTION TO THE SERIOUSNESS OF THIS MATTER. ORHS INTENDS TO CONTINUE WORKING ALONG WITH ALARIS TO INSURE THE IMED PUMPS MAINTAIN PROPER AND TIMELY MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMED PUMP IV PUMP FRN ALARIS MEDICAL SYSTEMS INC. CE28353 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other