BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WELLS JOHNSON INFUSION SYSTEM (WIS)

    MDR report key: 19968278 · Received August 12, 2024

    Report

    Report Number
    2024022-2024-00001
    Event Type
    Malfunction
    Date Received
    August 12, 2024
    Date of Event
    July 15, 2024
    Report Date
    November 21, 2024
    Manufacturer
    WELLS JOHNSON CO.
    Product Code
    FRN
    UDI-DI
    B458206000000Y
    PMA / PMN Number
    K991437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS A CORRECTION OF ERRORS IN THE INITIAL SUBMISSION UNDER MFR REPORT #: 2024022-2024-00001. FIRST CORRECTION IS IN SECTION D.3 THE CUSTOMER SERVICE EMAIL ADDRESS IS OMITTED. THE SECOND CORRECTION IS IN THE INITIAL REPORT REMEDIAL ACTION "REPAIR" IN SECTION H.7 WAS SELECTED INCORRECTLY. THERE WAS NO REMEDIAL ACTION FOR THIS DEVICE; THE ACTION TAKEN WAS TO CORRECT/REPAIR ONLY A SINGLE DEVICE.

    Description of Event or Problem · 0

    WELLS JOHNSON RECEIVED A REPORT (B)(6) MEDICAL CENTER OF (B)(6) THAT AN INFUSION PUMP WAS INCREASING THE FLOW RATE DURING A PROCEDURE. THE SURGEON WAS ABLE TO FINISH THE CASE WITHOUT REPLACING THE PUMP AND DIDN'T REPORT ANY IMPACT ON THE SAFETY OF THE PATIENT. THE DEVICE WAS SENT BACK FOR EVALUATION, AND IT WAS FOUND THAT THE POTENTIOMETER THAT CONTROLS FLOW RATE MALFUNCTIONED, PREVENTING THE FLOW RATE FROM BEING ADJUSTED LOWER. THE FLOW RATE DID NOT EXCEED THE MAX FLOW RATE ACCORDING TO UNIT SPECIFICATIONS. THE UNIT WAS REPAIRED AND SENT BACK TO THE CUSTOMER ON (B)(6) 2024. THIS WAS AN ISOLATED INCIDENT THAT HAS NOT BEEN OBSERVED IN THE LAST 2 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2484932 WELLS JOHNSON INFUSION SYSTEM (WIS) INFUSION PUMP FRN WELLS JOHNSON CO. 20600000 N/A B458206000000Y

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown