BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2162578 · Received July 14, 2011

    Report

    Report Number
    1423500-2011-09042
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    November 1, 2010
    Report Date
    June 22, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 2 OF 2 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H10A11029 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. THE CAUSE OF THE PERITONITIS WAS USE ERROR-POOR ASEPTIC TECHNIQUE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS NURSE REPORT FROM THE USA OF DID NOT WEAR A MASK AND PERITONITIS WITH (B)(6) COINCIDENT WITH DIANEAL PD4 ULTRABAG THERAPY FOR PERITONEAL DIALYSIS (PD). DURING A CALL TO BAXTER CUSTOMER SERVICE, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE IN 2010, THE PATIENT DID NOT WEAR A MASK, WHICH RESULTED IN PERITONITIS. ON AN UNREPORTED DATE IN (B)(6) 2010, THE PATIENT EXPERIENCED PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED. TREATMENT WAS NOT REPORTED. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE EVENT OF PERITONITIS. THE OUTCOME FOR THE EVENT OF DID NOT WEAR A MASK WAS NOT REPORTED. DIANEAL THERAPY WAS ONGOING. THE NURSE REPORTED THAT THE PERITONITIS WITH (B)(6) WAS UNRELATED TO DIANEAL THERAPY AND DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENT OF DID NOT WEAR A MASK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other HOMECHOICE| DIANEAL PD4 ULTRABAG