BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1871834 · Received October 16, 2010

    Report

    Report Number
    1423500-2010-04493
    Event Type
    Injury
    Date Received
    October 16, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 24, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE OF THE PERITONITIS WAS DUE TO POOR ASEPTIC TECHNIQUE. A LABELING REVIEW WAS COMPLETED AND FOUND TO BE ADEQUATE. A BATCH REVIEW WAS PERFORMED FOR THE SUSPECTED LOT NUMBERS (GD876490, GD875559, GD874826), WITH NO DEFECTS NOTED.

    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. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFO THAT ONE DAY POST IMPLANT, THE RIGHT VENTRICULAR (RV) LEAD WAS SUCCESSFULLY REPOSITIONED DUE TO DISLODGEMENT. NO ADVERSE PT EFFECTS WERE REPORTED. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFO BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ON AN UNREPORTED DATE IN 2009, THE PATIENT BEGAN PERITONEAL DIALYSIS (PD) TREATMENT. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE REPORTING NURSE STATED THAT ON AN UNREPORTED DATE IN 2010, THE PATIENT MADE MISTAKE/TOUCH CONTAMINATION. ON (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS WHICH DID NOT INVOLVE HOSPITALIZATION. IN (B)(6) 2010, A PERITONEAL EFFLUENT CULTURE WAS PERFORMED WHICH WAS POSITIVE FOR (B)(6) AND (B)(6). THE NURSE DID NOT PROVIDE INFORMATION REGARDING TREATMENT. IT WAS NOT REPORTED WHETHER PD THERAPY WAS ONGOING AT THE TIME OF THE EVENTS. THE PATIENT WAS RECOVERING FROM THE PERITONITIS. IT WAS NOT REPORTED WHETHER THE PATIENT WAS RETRAINED IN ASEPTIC TECHNIQUE. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. PER THE NURSE, THE EVENTS OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) AND FUNGAL PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) WERE NOT RELATED TO PD THERAPY. A CAUSAL RELATIONSHIP WAS NOT REPORTED FOR THE EVENT OF PATIENT MADE MISTAKE/TOUCH CONTAMINATION WITH REGARDS TO PD THERAPY.

    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 86 YR DIANEAL PD4 AMBUFLEX