BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2914546 · Received January 14, 2013

    Report

    Report Number
    1416980-2013-01011
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 29, 2012
    Report Date
    December 29, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A REPORT OF A LEAK WAS CONFIRMED. THE ROOT CAUSE WAS USE ERROR. A FOLLOW-UP MDR WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING AN ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING DRAIN 4 OF 4. THE HOME PATIENT (HP) STATED THAT HE WAS USING A STEP STOOL TO GET INTO BED AND IT PINCHED THE PATIENT LINE WHICH CAUSED A HOLE IN THE LINE AND RESULTED IN LEAKAGE. THE HP CLOSED THE PATIENT LINE AND ATTEMPTED TO PUT TAPE AROUND THE HOLE AND CONTINUE USING THE SET. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT HE WOULD NEED TO END THERAPY AND ADVISED THE HP TO CONTACT HIS REGISTERED NURSE ABOUT THE HOLE IN THE LINE. THE HP UNDERSTOOD. THE TSR ASSISTED WITH ENDING THERAPY. THE HP WOULD COMPLETE THERAPY MANUALLY. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. BAXTER PRODUCT SURVEILLANCE CONTACTED THE REGISTERED NURSE ON (B)(4) 2013. HE STATED THAT THE PATIENT HAD SPOKEN WITH HIM ABOUT THIS INCIDENT. THE PATIENT WAS PREVENTATIVELY ADMINISTERED ANTIOBIOTICS. THE NURSE WAS MONITORING THE PATIENT'S EFFLUENT AND IT HAD BEEN CLEAR SO FAR. THERE WERE NO ADVERSE EFFECTS REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20830 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR HOMECHOICE