BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2936226 · Received January 30, 2013

    Report

    Report Number
    1416980-2013-02361
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    December 1, 2012
    Report Date
    January 15, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 1 OF 5 INVOLVED IN THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS: H12K04022, AND H12J11029. NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. THE PROBLEM WAS NOT CONFIRMED AND THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED.

    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 FROM A NURSE IN THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER, THE FOLLOWING WAS REPORTED BY THE CONSUMER. ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS. THE CONSUMER STATED THAT HIS EXIT SITE WAS IRRITATED AND THIS MAY HAVE CAUSED THE PERITONITIS. THE PATIENT STATED THAT HE WAS RECOVERING. ON (B)(6) 2013, THE NURSE WAS CONTACTED AND CONFIRMED THAT ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS. TREATMENTS FOR THE EVENT WERE NOT REPORTED. THE NURSE CONFIRMED THAT THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE NURSE COULD NOT CONFIRM THE CAUSE OF THE PERITONITIS TO BE "EXIT SITE IRRITATED", AS REPORTED BY THE CONSUMER, AND STATED THE CAUSE OF THE EVENT WAS UNKNOWN. THE PATIENT WAS RE-TRAINED ON PROPER ASEPTIC TECHNIQUE. AT THE TIME OF THIS REPORT, THE PERITONITIS HAD RESOLVED AND PD THERAPY WAS ONGOING. THE NURSE CONSIDERED THE EVENT TO BE UNRELATED TO THE DIANEAL SOLUTION, HOMECHOICE MACHINE, AND ANY DISPOSABLE PARTS. NO FURTHER INFORMATION WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40258 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other DIANEAL PD4 AMBUFLEX