BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP EXTD LIFE TRANS SET W/TWIST CLAMP-EX SHORT

    MDR report key: 1813278 · Received August 24, 2010

    Report

    Report Number
    1423500-2010-02846
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 3, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS OPENED TO ADDRESS A PATIENT REACTION OF PERITONITIS. ROOT CAUSE FOR THE PERITONITIS WAS NOT IDENTIFIED DUE TO INSUFFICIENT INFORMATION AVAILABLE. SINCE NO SAMPLE WAS AVAILABLE FOR EVALUATION, NO ROOT CAUSE CAN BE DETERMINED THROUGH SAMPLE INSPECTION. NO SPECIFIC PRODUCT FAILURES WERE INDICATED IN THE COMPLAINT REPORT THAT COULD CONTRIBUTE TO PERITONITIS. A BATCH REVIEW WAS PERFORMED FOR SUSPECT LOT NUMBERS, WITH NO DEFECTS NOTED. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR(S) IN THIS COMPLAINT. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4)AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN, THE SAMPLE WAS NOT REQUESTED.

    Description of Event or Problem · 1

    THE SPIKE OF THE TRANSFER SET WAS NOT CONNECTED TO THE PORT OF A SOLUTION BAG BY CLEAN FLASH. THE SPIKE WAS NOT CONNECTED TO ANYTHING IN THE CLEAN FLASH. THE SET HAD BEEN USED FOR 45 DAYS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. THE ACTUAL SAMPLE WAS AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE REPORTING NURSE STATED THAT ON AN UNKNOWN DATE IN 2010, THE PATIENT DEVELOPED PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE NURSE STATED THAT THE "PATIENT GETS BOUNDS INFECTED EASILY, PATIENT HAS A PERMANENT PICKING LINE INSERTED DUE TO HEART MEDICATION THAT SHE NEEDS TO HAVE INDEFINITELY, SHE GETS THAT AREA INFECTED OFTEN." ON (B)(6)2010, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. TREATMENT INFORMATION WAS NOT PROVIDED. IN 2010, PD THERAPY WAS WITHDRAWN. IT WAS UNKNOWN WHETHER THE PERITONITIS RESOLVED. DURING FOLLOW-UP ON (B)(6)2010, IT WAS FOUND ON AN UNREPORTED DATE IN 2010, THE PD CATHETER WAS PULLED AND THE PATIENT WAS SWITCHED TO HEMODIALYSIS DUE TO THE PERITONITIS. THE RESULT OF THE CULTURE REMAINED UNKNOWN. THE NURSE "DID NOT KNOW THE BUG THAT CAUSED THE PERITONITIS." THE PATIENT HAD NOT RECOVERED FROM THE PERITONITIS AND REMAINED HOSPITALIZED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP EXTD LIFE TRANS SET W/TWIST CLAMP-EX SHORT SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R UNSPECIFIED HEART MEDICATION, DIANEAL PD4 ULTRABAG