BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPD DISCONNECT Y-SET, BULKPACK DISPOSABLE

    MDR report key: 1801301 · Received August 16, 2010

    Report

    Report Number
    1423500-2010-02526
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    July 16, 2010
    Report Date
    July 16, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K961825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. WHILE USER ERROR MAY CONTRIBUTE TO PERITONITIS, THERE IS NO INDICATION THAT USER ERROR, SUCH AS A BREAK IN ASEPTIC TECHNIQUE, CONTRIBUTED TO THIS EVENT.

    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.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WHICH EXPERIENCED FAILURE CODE 808:03 DURING SET-UP IN MEDICAL SURGERY. REVIEW OF THE DEVICE EVENT HISTORY DETERMINED THAT THIS CONDITION INTERRUPTED DELIVERY. THE FACILITY REPRESENTATIVE STATED THAT THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 6.13.90. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2010, A FOLLOW UP CALL WAS MADE TO THE PATIENT'S NURSE REGARDING THE ISSUES THE PATIENT WAS HAVING WITH FIBRIN AND INFECTION. THE NURSE STATED THAT THE FIBRIN IS AN ON AND OFF THING. THE NURSE STATED THAT THE PATIENT IS ADDING HEPARIN TO THE BAGS TO HELP CONTROL THIS ISSUE. THE NURSE STATED THAT THE INFECTION THE PATIENT MENTIONED WAS PERITONITIS. THE PERITONITIS WAS DIAGNOSED ON (B)(6) 2010 ALTHOUGH, THE NURSE STATED THEY SUSPECTED THE PATIENT HAD THE PERITONITIS EARLIER THEN THIS DATE. THE PERITONITIS WAS BACTERIAL. THE PATIENT WAS NOT HOSPITALIZED FOR THIS. THE NURSE DID NOT BELIEVE THAT THE SOLUTION OR DEVICE WAS THE CAUSE OF THE PERITONITIS, BUT DID NOT SAY WHAT HE THOUGHT THE CAUSE WAS. THE PATIENT'S RECOVERY IS ONGOING AND IMPROVING. THERE ARE NO ALLEGATIONS AGAINST ANY BAXTER PRODUCTS IN THIS CASE OF PERITONITIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention