BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD PUMP

    MDR report key: 12908551 · Received November 30, 2021

    Report

    Report Number
    MW5105682
    Event Type
    Malfunction
    Date Received
    November 30, 2021
    Date of Event
    November 18, 2021
    Report Date
    November 18, 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. PATIENT REPORTING CASSETTE MALFUNCTION. PT STATED THAT SHE HAS BEEN OFF HER INFUSION FOR ABOUT AN HOUR AT THIS POINT, TRYING TO TROUBLE SHOOT HER PUMP; "NO DISPOSABLE - PUMP WON'T RUN" ERROR MESSAGE WAS DISPLAYED ON THE SCREEN. PT TRIED USING A NEW MIX/ NEW CASSETTE/ NEW TUBING AND SWITCHING THE CASSETTE FROM ONE PUMP TO THE OTHER BUT KEPT GETTING THE SAME ERROR MESSAGE. DURING THE CONTACT WITH AUTHOR, PT TRIED ONE MORE TIME TO SWITCH TO THE OTHER PUMP AND WAS FINALLY ABLE TO GET THE INFUSION GOING AGAIN. NO SIDE EFFECTS OR CHANGES IN BREATHING WERE REPORTED. AUTHOR HAS INFORMED DOCTOR ABOUT THE EVENT. PUMP SERIAL NUMBERS ARE UNKNOWN. DEFECTIVE CASSETTE LOT 4163625. PHARMACY ONLY DISPENSED NEW CASSETTES. 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? YES; DID WE [MFR] REPLACE THE 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.

    Description of Event or Problem · 0

    ADDITIONAL INFO RECEIVED FROM REPORTER ON 12/9/2021 FOR MW5105682. SPONTANEOUS. FOLLOW UP TO PREVIOUSLY REPORTED EVENT. PT REPORTS THE BACKUP PUMP IS NOW GIVING A 'NO DISPOSABLE CLAMP TUBING' ALARM. PT CONTACTED PHARMACY EARLIER TODAY ABOUT THIS SAME ISSUE AND A NEW PUMP WAS SENT CONTACTED CNSS (B)(6)., TO CONTACT PT TO CONFIRM IF PT IS DOING SOMETHING INCORRECTLY OR IF SHE TRULY HAS A MALFUNCTIONING PUMP AND/ OR CASSETTE. PER CNSS, THE PROBLEM IS THE CASSETTES (LOT NUMBER 4163625]. PT TRIED 3 PUMPS AND THEY ALL CAME BACK WITH THIS SAME ERROR WHEN THE CASSETTES (LOT NUMBER 4163625] WERE ATTACHED. PT MADE ANOTHER NEW MIX (WITH SAME CASSETTE LOT NUMBER 4163625) AND WAS ABLE TO START THE PUMP. THE CASSETTES APPEAR TO ONLY LAST A FEW HOURS BEFORE THEY GIVE AN ERROR. NO OTHER INFORMATION KNOWN. PRESCRIBER HAS NOT BEEN NOTIFIED. HAS THIS INCIDENT HAPPENED WITH IN THE PAST 6 MONTHS? YES, OCCURRED EARLIER TODAY. HAS THIS PATIENT REPORTED A PUMP MALFUNCTION WITHIN THE PAST 6 MONTHS? NO. CNSS WAS ABLE TO GET THE PUMP TO INFUSE FOR THE PT. NEW CASSETTES WITH DIFFERENT LOT NUMBER WERE SENT FOR THE NEXT DAY. 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? YES; DID WE [MFR] REPLACE THE PRODUCT? YES; DID THE PT HAVE A BACKUP PRODUCT THEY WERE ABLE TO SWITCH TO? YES, THOUGH BOTH PUMPS WERE HAVING ISSUES WHEN THE CASSETTE LOT NUMBER 4163625 WAS ATTACHED. WAS THE PT ABLE TO SUCCESSFULLY CONTINUE THEIR THERAPY? YES; REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1800313 CADD PUMP SET, I.V, FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 6400 4163625

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female