BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2190187 · Received August 4, 2011

    Report

    Report Number
    1423500-2011-10238
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 15, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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 3 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4).UPON FURTHER INVESTIGATION IT HAS BEEN DETERMINED THAT NO ADDITIONAL FOLLOW UP OR INVESTIGATION IS REQUIRED AGAINST THE MINICAP TRANSFER SET DUE TO PRODUCT ALLEGATIONS AGAINST THE MINICAP. ALL INVESTIGATIONS PERFORMED RELATIVE TO THIS EVENT CAN BE FOUND IN REPORT NUMBER 1423500-2011-10239.

    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 A PATIENT'S CAP CAME OFF AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE CAREGIVER REPORTED THE FOLLOWING. ON (B)(6) 2011 PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED ON (B)(6) 2011. TREATMENT WAS NOT REPORTED. THE PATIENT WAS NOT RECOVERED. THE ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED. THE CONSUMER BELIEVED THE CAUSE OF PERITONITIS WAS BECAUSE THE PATIENT'S CAP CAME OFF WHILE THE NURSE WAS GIVING HIM A BATH AND THE PATIENT JUST PLACED THE CAP BACK ON. THE CONSUMER DID NOT PROVIDE AN OPINION ON THE EVENT OF PATIENT'S CAP CAME OFF.

    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 71 YR Hospitalization DIANEAL PD4 AMBUFLEX| HOMECHOICE