BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE

    MDR report key: 2862234 · Received December 7, 2012

    Report

    Report Number
    1416980-2012-06652
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4) REVIEW OF SERVICE HISTORY REVEALED NO FAILURES/PROBLEMS THAT WERE THE SAME AS, OR SIMILAR TO, THE REPORTED CONDITION, AND THERE WAS NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE IN THE USA OF BLOODY PINK DRAINAGE, SHORTNESS OF BREATH, FLUID BUILD UP, UMBILICAL HERNIA, PERITONITIS, HIGH NUMBER OF WHITE BLOOD CELLS, AND HIGH NUMBER OF RED BLOOD CELLS IN A FEMALE PATIENT COINCIDENT WITH DIANEAL PD2 AMBUFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 AMBUFLEX THERAPY INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DIANEAL THERAPY WAS ONGOING. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT HAD HERNIA. ON AN UNREPORTED DATE, THE PATIENT HAD HERNIA REPAIR SURGERY. ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS (PERITONITIS BEING REPORTED SEPARATELY). ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE, PERITONEAL EFFLUENT CULTURE WAS PERFORMED AND THE RESULT WAS UNKNOWN. THE PATIENT WAS NOT SURE BUT REPORTED THAT HERNIA REPAIR MIGHT BE THE CAUSE OF PERITONITIS. FOLLOW-UP INFORMATION ((B)(6) 2012): FURTHER INFORMATION WAS PROVIDED BY A NURSE. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED BLOODY PINK DRAINAGE, SHORTNESS OF BREATH, AND FLUID BUILDUP. ON AN UNREPORTED DATE 10 DAYS PRIOR TO HOSPITALIZATION, THE PATIENT UNDERWENT UMBILICAL HERNIA REPAIR SURGERY. ON (B)(6) 2012 (PREVIOUSLY (B)(6) 2012), THE PATIENT WAS HOSPITALIZED FOR PERITONITIS MANIFESTED BY ABDOMINAL PAIN. THE PATIENT WAS STARTED ON ANTIBIOTICS FOR PERITONITIS. TREATMENT FOR FLUID BUILD-UP IN THE HOSPITAL INCLUDED AGGRESSIVE FLUID REMOVAL WITH DIANEAL 4.25% SOLUTION AND WAS INSTRUCTED TO REDUCE ORAL FLUID INTAKE. THE NURSE COULD NOT CONFIRM IF THE PATIENT EXPERIENCED PERITONITIS. IT WAS UNKNOWN IF FIRST CULTURE WAS SIGNIFICANT FOR PERITONITIS AS THE NURSE DID NOT HAVE THE RESULTS FROM THE HOSPITAL. THESE EVENTS WERE CONSIDERED TO BE A RESULT OF RECENT UMBILICAL HERNIA REPAIR SURGERY AND LACK OF FLUID CONTROL. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

    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 Hospitalization| R DIANEAL PD2 AMBUFLEX