BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2771297 · Received October 3, 2012

    Report

    Report Number
    1416980-2012-01509
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    August 1, 2012
    Report Date
    September 12, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(4) 2012, FURTHER INFORMATION WAS RECEIVED FROM THE NURSE, WHO MEDICALLY CONFIRMED THE CASE. ON AN UNKNOWN DATE DURING HOSPITALIZATION, THE PATIENT'S PD CATHETER WAS PULLED AND DIANEAL AND EXTRANEAL THERAPIES WERE WITHDRAWN. ON (B)(6) 2012 (PREVIOUSLY REPORTED AS (B)(6) 2012), THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH VANCOMYCIN IP AND CEFEPIME IP. THE NURSE BELIEVED THE CAUSE OF PERITONITIS MAY HAVE BEEN TOUCH CONTAMINATION BUT COULD NOT CONFIRM. THE PATIENT WAS RE-TRAINED ON ASEPTIC TECHNIQUE. ON (B)(6) 2012 (PREVIOUSLY REPORTED AS (B)(6) 2012), THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2012, THE PATIENT WAS RE-HOSPITALIZED FOR THE PERITONITIS. TREATMENT WAS UNKNOWN. THE PATIENT REMAINED HOSPITALIZED. AT THE TIME OF THIS REPORT THE PATIENT WAS RECOVERING FROM THE PERITONITIS. PER THE NURSE, THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL THERAPY. A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H12C30049 AND H12B29043 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. THE PROBLEM WAS NOT CONFIRMED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. NO ASSIGNABLE CAUSE WAS DETERMINED.

    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 ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 4 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 IN (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND EXTRANEAL VIAFLEX THERAPIES FOR PERITONEAL DIALYSIS (PD). DIANEAL AND EXTRANEAL THERAPIES WERE ONGOING. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT DID NOT TURN ON THE AIR CONDITIONING TO COOL OFF BEFORE DIALYSIS WHICH LED TO PERITONITIS. ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. TREATMENT FOR THE EVENT WAS NOT REPORTED. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNREPORTED DATE THE PATIENT RECOVERED FROM THE EVENT OF PERITONITIS. AN OPINION OF CAUSALITY WAS NOT REPORTED FOR THE EVENT OF PERITONITIS.

    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 23 YR Hospitalization| R HOMECHOICE| EXTRANEAL VIAFLEX| DIANEAL PD4 AMBUFLEX