BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP CASS MS3

    MDR report key: 8050918 · Received November 7, 2018

    Report

    Report Number
    MW5081157
    Event Type
    Malfunction
    Date Received
    November 7, 2018
    Report Date
    October 25, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS CALL FROM PT, ONE OF PT'S PUMPS IS MALFUNCTIONING AND PT IS UNABLE TO USE IT. PUMP KEPT ALARMING. PT COULD NOT PROVIDE DETAILS SERIAL NUMBER. PT STATES THAT HER DAUGHTER WILL BE IN AT 1 PM. PUMP REPLACEMENT SCHEDULED. WILL CALL BACK 1 PM AS PT REQUESTED FOR FURTHER DETAILS. CALLED BACK AND WAS TOLD PT WOULD CALL BACK SINCE SHE HAD COMPANY. CALLED AGAIN ABOUT 2 HOURS LATER. PT'S DAUGHTER REQUESTED PHARMACY CALL BACK. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH A PT? UNK; DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PT OR CLINICAL INJURY? UNK. WE REPLACED THE DEVICE. DOSE OR AMOUNT: 50NKM, FREQUENCY: CONTINUOUS INFUSION: CONTINUOUS INFUSION, ROUTE: SQ. DATES OF USE: FROM (B)(6) 2013 TO CURRENT. DIAGNOSIS OR REASON FOR USE: PAH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889378 PUMP CASS MS3 PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1