BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1933499 · Received December 20, 2010

    Report

    Report Number
    1423500-2010-07081
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF BAXTER'S INVESTIGATION OF THIS REPORT, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED OPERATIONAL AND IN GOOD CONDITION. THE DEVICE PASSED THE HOMECHOICE RITE (RETURN INSTRUMENT TEST AND EVALUATION), FUNCTIONAL AND ELECTRICAL TESTS AND WAS FUNCTIONING WITHIN SPECIFICATION. AIR DETECTION CHECKS WERE PERFORMED IN EACH PHASE AND THE DEVICE FUNCTIONED PROPERLY BY ALARMING SE 2240 AND THEN A SE 2367 WHEN POWER WAS CYCLED. AT NO TIME DID THE DEVICE DELIVER AIR INTO THE PATIENT LINE. THERE WERE NO PROBLEMS FOUND DURING AN INTERNAL INSPECTION. A REVIEW OF THE DEVICE LOGS REVEALED NO ANOMALIES AND NO DRAIN OR UF VOLUMES THAT MEET THE IIPV (INCREASED INTRA-PERITONEAL VOLUME) CRITERIA. NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. THE ASSIGNABLE CAUSE WAS UNDETERMINED. THE DEVICE'S SERVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE AIR IN THE ABDOMEN AND CHEST. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING THE NURSE STATING THAT THE HOME PATIENT (HP) WENT TO THE EMERGENCY ROOM AND THEY FOUND THAT THE HP HAD AIR IN THE ABDOMEN AND CHEST AND HAD PAIN AFTER THEY DISCONNECTED FROM THE MACHINE, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE DISPOSABLES ARE A CLOSED SYSTEM AND THE MACHINE ITSELF JUST PUMPS ON THE CASSETTE. THE NURSE WANTED TO KNOW IF THERE WAS ANY WAY THE MACHINE COULD PUT AIR IN THE HP. THE TSR EXPLAINED THAT IT DID NOT SEEM POSSIBLE SINCE IT IS A CLOSED SYSTEM UNLESS THE HP DID NOT FOLLOW PROPER PROCEDURES. THE NURSE WANTED THE MACHINE SWAPPED. THE TSR WILL SWAP THE MACHINE. PRODUCT SURVEILLANCE CONTACTED THE HP'S NURSE (RN). THE RN STATED THAT THE HP WAS FINE AT THE MOMENT. THE HP DOES NOT KNOW HOW HE ABSORBED THE AIR. THERE WERE NO INJURIES REPORTED. THE RN STATED THAT THE HP IS NO LONGER IN ANY PAIN AND IS DOING WELL. NO FURTHER INFORMATION WAS RECEIVED FROM THE RN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE CYCLER-REFURBISHED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization| R