BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2864108 · Received December 10, 2012

    Report

    Report Number
    1416980-2012-06829
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 19, 2012
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    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). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB. A REVIEW OF THE DEVICE LOGS CONFIRMED THE REPORTED INCREASED INTRA-PERITONEAL VOLUME (IIPV); HOWEVER, THE IIPV WAS NOT DUPLICATED DURING EVALUATION. THE DEVICE WAS DETERMINED TO MEET ELECTRICAL AND FUNCTIONAL PERFORMANCE SPECIFICATIONS. NO DEVICE FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED IIPV. BASED ON THE INFORMATION GATHERED DURING BAXTER?S INVESTIGATION THE ROOT CAUSE WAS DETERMINED TO BE INSUFFICIENT DRAIN DUE TO A FALSE EMPTY DETECT AND USE ERROR, AN INAPPROPRIATE BYPASS OF A LOW DRAIN VOLUME ALARM NOT INCLUDING THE INITIAL DRAIN. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A HOME PATIENT (HP) REQUESTING TO END THERAPY ON THE HOMECHOICE (HC) DURING USE, DURING DRAIN 6 OF 7. THE DRAIN VOLUME EQUALED 3806ML. THE HP STATED SHE HAD A CRAMP IN HER STOMACH AND WANTED TO END THERAPY NOW. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP WITH ENDING THERAPY AND REMOVING THE CASSETTE. THE HC WAS OPERATIONAL. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE (PS) SPOKE WITH THE REGISTERED NURSE (RN) ON (B)(4) 2012, REGARDING THE REPORTED EVENT. THE NURSE STATED THAT SHE WAS MADE AWARE OF THIS EVENT. SHE STATED THAT THE PATIENT'S LARGEST PRESCRIBED FILL VOLUME (LPFV) IS 2000ML. THEREFORE, THIS COMPLAINT MEETS INCREASED INTRA-PERITONEAL VOLUME (IIPV) CRITERIA (ANY THERAPY WHERE THE PATIENT VOLUME EXCEEDS 160% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME). SHE STATED THAT THEY HAD RECENTLY INCREASED THE PATIENT'S LAST FILL VOLUME TO 500ML. SHE REPORTED THAT THE PATIENT IS DRAINING MOST OF THIS OUT DURING THE INITIAL DRAIN. SHE STATED THE PATIENT HAS BEEN DOING FINE SINCE THEN. SHE STATED THAT THE PATIENT HAS BEEN ABLE TO CONTINUE THERAPY ON THE CYCLER SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ALLEGATIONS WERE MADE AGAINST ANY BAXTER PRODUCTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE