BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE

    MDR report key: 2222267 · Received August 24, 2011

    Report

    Report Number
    1423500-2011-11206
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 2, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE COMPLAINT WAS CONFIRMED BUT THE ROOT CAUSE WAS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE REGISTERED NURSE (RN) CONTACTED PRODUCT SURVEILLANCE ON (B)(6) 2011 TO REPORT THAT THE CAREGIVER (CG) STATED THAT THE CASSETTE SHE OPENED ON (B)(6) 2011 WAS "DIRTY". THE "DIRTY" CASSETTE WAS FOUND DURING SET UP. THE CG DID NOT USE THE CASSETTE. THE LOT NUMBER IS UNKNOWN. THE NURSE DID NOT HAVE ADDITIONAL DETAILS AT THE TIME OF THE CALL. THE STATED THAT SHE WOULD CALL THE CAREGIVER BACK TO GET ADDITIONAL DETAILS REGARDING WHAT WAS FOUND IN AND/ OR ON THE CASSETTE THAT THE CAREGIVER CONSIDERED AS DIRTY. THERE WAS NO PATIENT INVOLVEMENT. THE REGISTERED NURSE (RN) CONTACTED PRODUCT SURVEILLANCE ON (B)(6) 2011 REGARDING THE CAREGIVER'S (CG) REPORT OF A "DIRTY CASSETTE". THE NURSE STATED THE CG BROUGHT HER IN THE CASSETTE. THE RN SAW THAT ON THE CASSETTE THERE WERE 3 TINY AIR BUBBLES IN THE PLASTIC. THE RN STATED THAT IT APPEARED THAT THE AIR BUBBLES WERE CAUGHT BETWEEN THE LAYERS OF PLASTIC. THE RN COULD MOVE OR SCRAP OFF THE AIR BUBBLES. THE RN HAD CIRCLED THE SPOTS ON THE CASSETTE AND WILL HOLD FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H11C08012

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO HOMECHOICE