BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD EXT SET

    MDR report key: 15079492 · Received July 20, 2022

    Report

    Report Number
    MW5111043
    Event Type
    Malfunction
    Date Received
    July 20, 2022
    Report Date
    April 9, 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

    PT REPORTS DEFECTIVE TUBING (LOT NUMBER 4220038, QUANTITY 8 AND LOT NUMBER 4135484, QUANTITY 1) IS RELATED TO PREVIOUSLY REPORTED CASSETTE ISSUE. PT PREVIOUSLY REPORTED THAT 2 CASSETTES FROM LOT NUMBER 4235231 WOULD NOT READ ON PUMPS. PT CONFIRMED THIS WAS A CASSETTE AND TUBING ISSUE, NOT A PUMP ISSUE. ALL DEFECTIVE TUBING WAS ALREADY RETURNED TO THE MFR ALONG WITH THE PREVIOUSLY REPORTED DEFECTIVE CASSETTES. NO ADDITIONAL INFO, DETAILS OR DATES ARE AVAILABLE AT THIS TIME. PUMP RETURN TRACKING INFORMATION IS NOT AVAILABLE. PHOTOGRAPHS WERE NOT PROVIDED. THIS IS A CONTINUOUS INFUSION. SET FLOW RATE AND VOLUME DELIVERED ARE UNKNOWN. POSITION OF THE PUMP WHEN ALARM OCCURRED IS UNKNOWN. 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, ALREADY RETURNED TO MFR. DID [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 CVS/CAREMARK BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88512 CADD EXT SET SET, ADMINISTRATION, INTRAVASCULAR LHI SMITHS MEDICAL ASD, INC. UNK
    88513 CADD EXT SET SET, ADMINISTRATION, INTRAVASCULAR LHI SMITHS MEDICAL ASD, INC.
    88514 CADD EXT SET SET, ADMINISTRATION, INTRAVASCULAR LHI SMITHS MEDICAL ASD, INC.
    88515 CADD EXT SET SET, ADMINISTRATION, INTRAVASCULAR LHI SMITHS MEDICAL ASD, INC.
    88516 CADD EXT SET SET, ADMINISTRATION, INTRAVASCULAR LHI SMITHS MEDICAL ASD, INC.
    88517 CADD EXT SET SET, ADMINISTRATION, INTRAVASCULAR LHI SMITHS MEDICAL ASD, INC.
    88518 CADD EXT SET SET, ADMINISTRATION, INTRAVASCULAR LHI SMITHS MEDICAL ASD, INC.
    88519 CADD EXT SET SET, ADMINISTRATION, INTRAVASCULAR LHI SMITHS MEDICAL ASD, INC.
    88520 CADD EXT SET SET, ADMINISTRATION, INTRAVASCULAR LHI SMITHS MEDICAL ASD, INC.
    88521 CASSETTES SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC.
    88522 CASSETTES SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female