BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2111973 · Received June 2, 2011

    Report

    Report Number
    1423500-2011-07019
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 8, 2011
    Report Date
    May 9, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT FOR A LEAK WAS CAUSED BY THE TUBING HOLE. A BATCH REVIEW WAS PERFORMED WITH NO ISSUES NOTED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, BAXTER CANNOT DETERMINE THE ROOT CAUSE. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A CUSTOMER REPORTED 2 CASSETTES WITH DEFECTS. THE CUSTOMER STATED THAT THIS IS THE SECOND CASSETTE WITH WHICH HE'S HAD A PROBLEM FROM THE SAME BOX. THE PATIENT STATED HE WAS TOO TIRED TO NOTE SPECIFICS WITH THE FIRST CASSETTE, HOWEVER, WHEN THE SECOND EVENT HAPPENED, HE AWOKE FROM HIS SLEEP BECAUSE HIS BED WAS WET. THE MACHINE DID NOT ALARM AT ALL. THE PATIENT PUT HIS EAR TO THE TUBE AND COULD HEAR A HISSING SOUND AND SEE BUBBLES IN THE LINE. THERE WAS A PIN HOLE IN THE LINE. THE PATIENT DISCARDED THE BAGS AND RE-DID THE SETUP. THE PATIENT WILL CALL HIS NURSE. ON (B)(6) 2011, THE PATIENT LEFT A VOICEMAIL TO THE HOME PATIENT REPRESENTATIVE STATING THAT THE DEFECT IN THE TUBE, WAS NOT A DEFECT AT ALL. THE PATIENT NOTICED THAT THE COT HE WAS SLEEPING ON HAD A SHARP SPRING STICKING UP FROM UNDERNEATH AND THAT HE HAD PRICKED THE TUBE BY MISTAKE WHEN ROLLING OVER IN THE MIDDLE OF THE NIGHT, AS IT HAD JUST HAPPENED AGAIN. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS ADDRESSING CASSETTE 2 OF 3.

    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 H10K19071

    Patients

    Seq Age Sex Outcome Treatment
    1