BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1893475 · Received November 8, 2010

    Report

    Report Number
    1423500-2010-05462
    Event Type
    Injury
    Date Received
    November 8, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 23, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS (GD875575 AND GD877266), WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. CURRENT LABELING PROVIDES AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE SUSPECTED USE ERROR IN ASEPTIC TECHNIQUE. BAXTER HAS RECEIVED SIMILAR REPORTS. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    DURING A CALL FOR AN UNRELATED ALARM, THE PATIENT INDICATED SHE HAD PERITONITIS. THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED ON (B)(6) 2010: THE PATIENT HAS BEEN ON AUTOMATED PERITONEAL DIALYSIS (APD) WITH LOCAL (PD4) SOLUTION SINCE 2008. THE PATIENT WAS IN THE HOSPITAL ON (B)(6) 2010 FOR A TRANSFUSION. THE PATIENT?S PD EFFLUENT WAS ANALYZED ON (B)(6) 2010. THE CELL COUNT SHOWED 2% EOSINOPHILS AND 2% LYMPHOCYTES. THE GRAM STAIN AND CULTURE SHOWED (B)(6). THE PATIENT WAS ADVISED BY THE PD NURSE NOT TO DO THERAPY WHILE IN THE HOSPITAL AND THE PATIENT?S NEPHROLOGIST ORDERED MANUAL THERAPY. IT WAS INDICATED THE HOSPITAL STAFF SET UP THERAPY, NOT THE PATIENT. IT WAS INDICATED THAT THE PATIENT EXPERIENCED SYMPTOMS STARTING ON (B)(6) 2010 AND WAS DIAGNOSED WITH BACTERIAL PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS, AND THERE WAS NO EXIT SITE OR TUNNEL INFECTION INVOLVED. THE PATIENT WAS TREATED WITH VANCOMYCIN AND THE PERITONITIS IS CONSIDERED TO BE ONGOING AND IMPROVING. THE NURSE INDICATED THE CAUSE OF THE PERITONITIS WAS THE MANUAL EXCHANGES PERFORMED BY THE HOSPITAL STAFF. THERE WAS NO ALLEGATION MADE AGAINST THE BAXTER PRODUCTS. NO FURTHER INFORMATION IS AVAILABLE. REPORT 1 OF 2.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. NO KNOWN CAUSE OR DEVICE ISSUE WAS REPORTED. THERE IS NO ALLEGATION FROM A HEALTHCARE PROFESSIONAL THAT THE DEATH IS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI-CAP, DISCONNECT W/PVP-1SOLUTION DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention