BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE

    MDR report key: 2223655 · Received August 25, 2011

    Report

    Report Number
    1423500-2011-11256
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 10, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORT OF AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS CONFIRMED IN THE DEVICE EVENT LOG. THE ASSIGNABLE CAUSE FOR THE IIPV EVENT WAS DETERMINED TO BE INSUFFICIENT DRAIN; FALSE EMPTY DETECT AND USE ERROR- INITIAL DRAIN ALARM SETTING INAPPROPRIATELY PROGRAMMED. A LABELING REVIEW WAS PERFORMED AND THE LABELING WAS FOUND TO BE ACCURATE AND SUFFICIENT REGARDING THE INITIAL DRAIN ALARM SETTING. THE DEVICE WAS RETURNED AND PASSED BOTH THE HOMECHOICE RITE ELECTRICAL TEST AND THE HOMECHOICE RITE FUNCTIONAL TEST AND WAS DETERMINED TO MEET PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE TESTING. THE PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WERE IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN REQUESTED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4).THE HOME PATIENT REFUSED TO RETURN THE DEVICE FOR EVALUATION.

    Description of Event or Problem · 1

    A HOME PATIENT'S (HP) PERITONEAL DIALYSIS (PD) NURSE CONTACTED BAXTER'S TECHNICAL SERVICE REPRESENTATIVE TO REPORT AN OVERFILL EPISODE THAT OCCURRED ON (B)(6) 2011. PER THE PD NURSE, THE HP WAS EXPERIENCING SHORTNESS OF BREATH, NAUSEA, FULLNESS AND DIAPHORESIS. THE HP CONTACTED BAXTER AND THE TSR HAD THE HP INITIATE A MANUAL DRAIN. THE HP'S SYMPTOMS IMMEDIATELY RESOLVED. THERAPY WAS NOT COMPLETED THAT NIGHT. THE HP CALLED 911 AND THE PARAMEDICS EVALUATED HIM, BUT THE HP DID NOT RECEIVE MEDICAL TREATMENT AND WAS NOT TRANSPORTED TO THE HOSPITAL. THE PD NURSE STATED SHE VISITED THE HP ON (B)(6) 2011 AND REVIEWED THE HP'S THERAPY. THE PD NURSE REPORTED THE HP DRAINED 16ML IN THE INITIAL DRAIN AND 5300ML DURING DRAIN 1. THE HP'S FILL VOLUME IS 2500ML. THE HP DOES PERFORM A MANUAL EXCHANGE OF 2000ML IN THE EVENING AND IS A LOW-AVERAGE TRANSPORTER. THE HP IS GOING TO HAVE TWO BACK-UP HEMODIALYSIS TREATMENTS AT THE REQUEST OF THE FAMILY AND RESUME PD THERAPY NEXT WEEK. NO FURTHER INFORMATION WAS PROVIDED.

    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 81 YR Other