BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE

    MDR report key: 2242015 · Received September 9, 2011

    Report

    Report Number
    1423500-2011-12018
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    June 1, 2011
    Report Date
    August 23, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H11A06077 AND H10D07013 AND 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SPECIFIC PRODUCT CODE FOR THE HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE IS UNKNOWN. THE BRAND NAME, MANUFACTURE AND 510K; HOWEVER HAVE BEEN PROVIDED IN THIS MDR. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 1 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM THE USA OF FEVER AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 AMBUFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE FOLLOWING INFORMATION WAS REPORTED. THE NURSE STATED THAT IN (B)(6) 2011, THE PATIENT EXPERIENCED FEVER AND PERITONITIS. ON AN UNREPORTED DATE IN (B)(6) 2011, THE PATIENT WAS HOSPITALIZED. TREATMENT WAS NOT REPORTED. ON AN UNREPORTED DATE, IN (B)(6) 2011, THE PATIENT WAS DISCHARGED. OUTCOME FOR THE EVENT OF PERITONITIS WAS NOT REPORTED. DIANEAL THERAPY WAS ONGOING. THE NURSE STATED THAT THE EVENTS OF FEVER AND PERITONITIS WERE UNRELATED TO DIANEAL THERAPY. AN OPINION OF CAUSALITY WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Hospitalization HOMECHOICE| DIANEAL PD2 AMBUFLEX