BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD PUMP AND CASSETTE LEGACY

    MDR report key: 12975670 · Received December 9, 2021

    Report

    Report Number
    MW5105944
    Event Type
    Malfunction
    Date Received
    December 9, 2021
    Report Date
    December 4, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SPONTANEOUS. PT'S SPOUSE REPORTING THAT AFTER RUNNING FOR 6 HOURS THE PUMP WILL ALARM WITH NO ERROR MESSAGE AND MEDICATION IS NO LONGER RUNNING. THEY MIXED NEW CASSETTE AND WERE ABLE TO CONTINUE INFUSION; NO ADVERSE EFFECTS REPORTED. AFFECTED CASSETTE LOT NUMBER 4163625/ EXPIRATION DATE 07/15/2026; NOT AVAILABLE FOR RETURN. PUMP SERIAL NUMBER NOT PROVIDED. PATIENT WAS ALREADY SENT A REPLACEMENT PUMP ON 12/03/2021 AND PUMP DOES NOT SEEM TO BE THE PROBLEM IN THIS CASE. PATIENT SENT REPLACEMENT CASSETTES ONLY. NO OTHER INFORMATION AVAILABLE. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PT? YES; DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PT OR CLINICAL INJURY? NO; IS THE ACTUAL PRODUCT AVAILABLE FOR INVESTIGATION? NO; DID WE [MFR] REPLACE PRODUCT? YES; DID THE PT HAVE A BACKUP PRODUCT THEY WERE ABLE TO SWITCH TO? YES; WAS THE PT ABLE TO SUCCESSFULLY CONTINUE THEIR THERAPY? YES; IS THE THERAPY LIFE-SUSTAINING? YES. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1863924 CADD PUMP AND CASSETTE LEGACY PUMP, INFUSION LHI SMITHS MEDICAL ASD, INC. 6400
    1863926 CASSETTE MEDI RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4163625

    Patients

    Seq Age Sex Outcome Treatment
    1 Female