BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASSETTE

    MDR report key: 13514508 · Received February 10, 2022

    Report

    Report Number
    MW5107399
    Event Type
    Malfunction
    Date Received
    February 10, 2022
    Date of Event
    February 6, 2022
    Report Date
    February 6, 2022
    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. FOLLOW UP REPORT. PT REPORTS PUMP SERIAL NUMBER (B)(4) JUST STARTED ALARMING NO DISPOSABLE. PT SWITCHED TO THE PUMP THAT ALARMED WITH NO CODE EARLIER TODAY, SERIAL NUMBER (B)(4). ADVISED PT THAT THIS IS USUALLY MORE OF A CASSETTE ISSUE THAN A PUMP ISSUE. PT MOST RECENTLY USED CASSETTE LOT NUMBER 4173641. PT REPORTS HAS A NEW REFILL OF CASSETTES WITH DIFFERENT LOT NUMBER AVAILABLE FOR USE AND WILL PREMIX A NEW CASSETTE IN CASE OF ANOTHER PUMP ERROR LATER. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PATIENT? YES; DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY? NO; IS THE ACTUAL DEVICE AVAILABLE FOR INVESTIGATION? NO; DID WE REPLACE DEVICE? NO; DID THE PATIENT HAVE A BACKUP DEVICE THEY WERE ABLE TO SWITCH TO? YES; IF YES, WAS THE PATIENT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? YES. IS THE INFUSION LIFE-SUSTAINING? YES; WHAT IS THE OUTCOME OF THE EVENT? RESOLVED. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112182 CADD PUMP PUMP, INFUSION LHI SMITHS MEDICAL ASD, INC. 6400
    76337 CASSETTE SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4173641
    76338 CADD PUMP PUMP, INFUSION LHI SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female