BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 2863668 · Received December 10, 2012

    Report

    Report Number
    1416980-2012-06716
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 16, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A LABELING REVIEW WAS PERFORMED AND THE INSTRUCTIONS ARE ACCURATE AND PROVIDE SUFFICIENT LEVEL OF DETAIL ON PREVENTING THE USE ERROR - REUSE OF SINGLE-USE PRODUCT ISSUE. THIS REVIEW FINDS THE LABELING ADEQUATE FOR THE RELATED USE ERROR(S) IN THE COMPLAINT. COMPLAINT IS CONFIRMED BECAUSE IT WAS REPORTED PATIENT SWAPPED THE CASSETTE ONLY WHILE ORDERING SUPPLIES, WHICH IS A USE ERROR/POOR ASEPTIC TECHNIQUE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAD BEEN DISCARDED AND THE LOT NUMBER WAS UNKNOWN, A BATCH REVIEW COULD NOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    HOME CARE SERVICES (HCSR) CONTACTED CORPORATE PRODUCT SURVEILLANCE TO STATE THAT A HOME PATIENT (HP) BRIEFLY MENTIONED THAT HE HAD TO 'SWAP THE CASSETTE' ON THE HOME CHOICE MACHINE WHILE ORDERING SUPPLIES. HCSR INQUIRED ABOUT THE REPORTED PROBLEM AND HP SAID HE REALLY DIDN'T WANT TO CALL IT IN OR MAKE A BIG DEAL OUT OF IT. HE SAID HE SWAPPED THE CASSETTE AND RESUMED WITH THERAPY. HP DID NOT PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE REPORTED PROBLEM INCLUDING SAMPLE OR LOT NUMBER. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR HOMECHOICE