BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1901371 · Received November 17, 2010

    Report

    Report Number
    1423500-2010-05880
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 PERFORMED AND FOUND TO BE ADEQUATE. A BATCH REVIEW WAS PERFORMED ON POTENTIALLY RELATED LOT NUMBERS (GD874834, GD877274, GD875567), WITH NO DEFECTS NOTED. PER THE INITIAL REPORT, THE PATIENT WAS RETRAINED ON ASEPTIC TECHNIQUE.

    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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    TECHNICIAN ALLEGED THAT THE BRAKE CASTERS NO LONGER HOLD WHEN THE BRAKE IS SET. NO PT IMPACT.

    Description of Event or Problem · 1

    ON AN UNREPORTED DATE THE PATIENT BEGAN PERITONEAL DIALYSIS (PD) TREATMENT WITH DIANEAL PD4 AMBUFLEX, 2.4 LITERS/4 CYCLES WITH A LAST FILL OF 2 LITERS (FREQUENCY NOT REPORTED) (TOTAL DAILY FILL 11.6 LITERS), AND DIANEAL PD4 ULTRABAG, 2 LITER MIDDAY CYCLE, INTRAPERITONEALLY (IP) FOR AUTOMATED PERITONEAL DIALYSIS (APD) AND CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON (B)(6) 2010, A SAMPLE OF PERITONEAL EFFLUENT WAS CULTURED AND A GRAM STAIN WAS PERFORMED TO SEE IF THE PREVIOUS EVENT OF BACTERIAL PERITONITIS HAD RESOLVED. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH BACTERIAL PERITONITIS. THE NURSE REPORTED THAT THIS WAS A DIFFERENT BACTERIA FROM THE FIRST EPISODE OF PERITONITIS. THE PATIENT DID NOT REQUIRE HOSPITALIZATION. THE PATIENT WAS TREATED WITH VANCOMYCIN IP (DOSE, FREQUENCY AND ADMINISTRATION DATES NOT REPORTED). THERE WAS NO EVIDENCE OF A TUNNEL OR EXIT SITE INFECTION. ON (B)(6) 2010, THE PATIENT HAD A REPEAT GRAM STAIN PERFORMED. THE RESULTS SHOWED GRAM POSITIVE WITH 4 (FEW) WBC(S). AT THE TIME OF REPORTING, THE BACTERIAL PERITONITIS RESOLVED. ON (B)(6) 2010, THE PATIENT COMPLETED ANTIBIOTIC THERAPY. THE ROOT CAUSE OF THE BACTERIAL PERITONITIS WAS UNKNOWN, BUT THE NURSE BELIEVED THAT THERE WAS POSSIBLE CONTAMINATION. THE PATIENT WAS RETRAINED ON ASEPTIC TECHNIQUE. PD THERAPY WAS NOT INTERRUPTED AND THE DOSAGE WAS NOT CHANGED. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED.

    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 85 YR Required Intervention DIANEAL PD4 AMBUFLEX, DIANEAL PD4 ULTRABAG