BEUDAMED
    FDA Adverse Event Injury Summary report: N

    K883239

    MDR report key: 1446930 · Received August 24, 2009

    Report

    Report Number
    1423500-2009-00385
    Event Type
    Injury
    Date Received
    August 24, 2009
    Date of Event
    July 26, 2009
    Report Date
    July 29, 2009
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K883239
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: DURING VISUAL INSPECTION NO MANUFACTURING ABNORMALITIES WERE NOTED. FUNCTIONALLY HAND TIGHTENED A LAB TITANIUM ADAPTER WITHOUT DIFFICULTY AND TESTED SET UNDERWATER AT 8 PSI WITH NO LEAKS OR ISSUES NOTED. THE COMPLAINT COULD NOT BE CONFIRMED IN THE LAB.

    Description of Event or Problem · 1

    IN 2009, BAXTER WAS NOTIFIED FROM A NURSE THAT THE PATIENT'S CATHETER TITANIUM ADAPTER SEPARATED FROM THE PATIENT ADAPTER OF THE TRANSFER SET IN 2009, AFTER MORE THAN 2 MONTHS USE AND THE PATIENT CONTRACTED PERITONITIS. THE PATIENT RECONNECTED THE TITANIUM ADAPTER AND THE PATIENT CONNECTOR. TWO DAYS LATER, IN THE DAYTIME, HE CAME TO THE HOSPITAL. HIS UV TRANSFER SET WAS EXCHANGED TO NEW ONE. AT THAT TIME, HE HAD NO SYMPTOM (NO PERITONEAL CLOUDY EFFLUENT, NO ABDOMINAL PAIN). ON THE SAME DATE, AT NIGHT, HE HAD ABDOMINAL PAIN AND CAME TO THE HOSPITAL AGAIN. HE WAS DIAGNOSED WITH PERITONITIS. HE WAS HOSPITALIZED AND TREATED WITH ANTIBIOTICS (VANCOMYCIN AND EXACIN). THE PATIENT IS A MALE USING DIANEAL-N AND EXTRANEAL THERAPY. APPROX THREE MONTHS PRIOR TO ORIGINAL DATE, THE PATIENT BEGAN PERITONEAL DIALYSIS THERAPY. FIVE DAYS PRIOR TO ORIGINAL DATE, HE CHANGED HIS PERITONEAL DIALYSIS REGIMEN TO DIANEAL N PD-4 UV TWINBAG 2.5% 2000MILLILITERS (ML) X 3TIMES AND EXTRANEAL UV TWINBAG 2000ML X 1TIME/DAY. AS OF ORIGINAL DATE, THE PATIENT WAS NOT RECOVERED FROM THE EVENT. THE NURSE STATED THE PERITONITIS WAS SERIOUS AND NOT RELATED TO DIANEAL N OR EXTRANEAL. THE NURSE THOUGHT THAT THE PERITONITIS MIGHT BE RELATED TO THE BREAK IN ASEPTIC TECHNIQUE. THE NURSE ASKED BAXTER TO INVESTIGATE THE UV TRANSFER SET AND RESOLVE WHAT WAS THE FACT AND ROOT CAUSE. THE FOLLOWING MONTH, A NURSE STATED THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. TWO DAYS LATER, A PHYSICIAN STATED THE FOLLOWING: HIS ASSESSMENT ABOUT SERIOUSNESS AND CAUSALITY OF THE EVENT WAS SAME AS THE NURSE'S. THE PATIENT WAS RECOVERED FROM THE EVENT AND DISCHARGED FROM THE HOSPITAL THAT MONTH. THE PERITONEAL EFFLUENT CULTURE WAS NOT AVAILABLE. TEST RESULTS TO MRSA (METHYCILLIN-RESISTANT STAPHYLOCOCCUS AUREUS) REVEALED A NEGATIVE RESULT. THE ACTUAL SAMPLE IS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K883239 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R