BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOME CHOICEPRO

    MDR report key: 2032991 · Received March 29, 2011

    Report

    Report Number
    1423500-2011-03814
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE OF ALARM WAS VERY SOFT; UNABLE TO INCREASE VOLUME WAS DUPLICATED DURING THE EVALUATION PERFORMED BY THE PAL (PRODUCT ANALYSIS LAB). THE DEVICE WAS RECEIVED OPERATIONAL AND IN GOOD CONDITION. THE DEVICE PASSED THE HOMECHOICE RITE (RETURN INSTRUMENT TEST / EVALUATION), FUNCTIONAL AND ELECTRICAL TESTS AND WAS FUNCTIONING WITHIN SPECIFICATION. THE PAL EVALUATED THE DEVICE. THE DEVICE POWERED UP PROPERLY. THE SPEAKER VOLUME ADJUSTMENT WAS TESTED. THE ALARM VOLUME WAS FOUND TO BE WEAK AT THE MAXIMUM SETTING. THE SPEAKER ASSEMBLY WAS REPLACED WITH THE TEST ARTICLE AND NORMAL SPEAKER VOLUME WAS RESTORED. THERE WERE NO PROBLEMS FOUND DURING AN INTERNAL INSPECTION. THE ASSIGNABLE CAUSE FOR THE REPORTED ISSUE OF ALARM WAS VERY SOFT; UNABLE TO INCREASE VOLUME WAS DETERMINED TO BE MALFUNCTIONING SPEAKER ASSEMBLY. THE DEVICE'S SERVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE LOW ALARM VOLUME. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT 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

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT AN INAUDIBLE ALARM ON A HOMECHOICE (HC) MACHINE THAT REPEATED DURING USE, PATIENT NOT CONNECTED. NURSE STATED SHE CANNOT ADJUST THE LOUDNESS ON THE MACHINE. SHE HAD TRIED TO INCREASE THE VOLUME OF THE ALARM AS IT WAS VERY SOFT, BUT WAS UNABLE TO INCREASE THE VOLUME. SHE REQUESTED A SWAP. THIS WAS THE FIRST CLINICAL USE OF A NEW OR REFURBISHED DEVICE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) INITIATED A SWAP OF THE DEVICE. THE TSR DISCUSSED THE USE OF CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) UNTIL THE NEW MACHINE ARRIVES. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE