BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2152892 · Received July 7, 2011

    Report

    Report Number
    1423500-2011-08754
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 12, 2011
    Report Date
    June 12, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS REQUESTED, BUT WAS NOT AVAILABLE. A FOLLOW-UP MDR WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT FOR A LEAK WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE IDENTIFIED. THE LOT NUMBER WAS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT CONDUCTED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING OF AN INCOMPLETE PRIME, THE HOME PATIENT (HP) REVEALED THAT THE PATIENT LINE FELL TO THE FLOOR AND THE CAP LOOSENED. SOLUTION CAME OUT OF THE PATIENT LINE. THE HP SAID IT SEEMED LIKE THE CAP WAS NOT ON VERY WELL BECAUSE THE WHITE PART WAS A LITTLE CRUSHED. THE HP SAID SHE DID NOT LOOK AT THE CAP OR TOP OF THE PATIENT LINE BEFORE IT FELL, SO SHE ONLY NOTICED THE DAMAGE AFTER. THE HP SAID THE CAP LOOKED CROOKED WHEN SHE WENT TO PICK IT UP, AND WHEN SHE TRIED TO TIGHTEN IT WOULDN'T GO ON ANY FURTHER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR HOMECHOICE