BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2923003 · Received January 18, 2013

    Report

    Report Number
    1416980-2013-01440
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 29, 2012
    Report Date
    December 29, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED DRAIN VOLUME MEETING IIPV CRITERIA WAS NOT CONFIRMED. REVIEW OF SERVICE HISTORY REVEALED NO FAILURES/PROBLEMS THAT WERE THE SAME AS, OR SIMILAR TO, THE CURRENT DIFFICULTY AND THERE WAS NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. REVIEW OF THE DEVICE. THE ROOT CAUSE WAS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO BAXTER. 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 CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REQUEST ASSISTANCE WITH A BYPASS OF A DRAIN ON A HOMECHOICE (HC) DURING USE, PATIENT CONNECTED DURING DRAIN. THE HOME PATIENT (HP) WAS IN DRAIN 5 OF 5 AND THE DRAIN VOLUME (DV) EQUALED 3367ML. THE HP WAS HAVING DRAIN PAINS. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO BYPASS TO END OF THERAPY. PRODUCT SURVEILLANCE SPOKE WITH THE PERITONEAL DIALYSIS REGISTERED NURSE (RN) AT THE CLINIC ON (B)(6) 2013 REGARDING THE REPORTED INCIDENT. THE RN STATED THAT THE HP HAD ISSUES WITH THE CATHETER AND RECENTLY HAD IT REPLACED. THE RN STATED THAT THE HP WAS NOT CURRENTLY PERFORMING PERITONEAL DIALYSIS THERAPY BECAUSE OF THE CATHETER REPLACEMENT. THE RN STATED THAT THEY DID NOT HAVE THE PATIENT'S LARGEST PRESCRIBED FILL VOLUME ON HAND AT THE MOMENT BUT THE NURSE BELIEVED THE VOLUME WAS 2000ML. THE RN STATED THAT AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT DID NOT OCCUR AND THAT THE PATIENT WAS DOING FINE NOW. THE RN STATED THAT DRAIN VOLUME REPORTED MUST HAVE BEEN AN ERROR OR A MISUNDERSTANDING. THERE WAS PATIENT INVOLVEMENT BUT NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE HC WAS OPERATIONAL. THERE WAS PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27684 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE