BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1971255 · Received January 26, 2011

    Report

    Report Number
    1423500-2011-01067
    Event Type
    Injury
    Date Received
    January 26, 2011
    Date of Event
    November 1, 2010
    Report Date
    December 28, 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). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD878223 AND GD877266 WITH NO DEFECTS NOTED. ROOT CAUSE FOR THE PERITONITIS IS THE PATIENT'S MEDICAL CONDITION, URINARY TRACT INFECTION (UTI). SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF THIS PERITONITIS EPISODE IS UNKNOWN, AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF FURTHER INFORMATION AND THE COMPLETION OF BAXTER'S INVESTIGATION. THIS IS THE FIRST OF FOUR COMPLAINTS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    BAXTER CONTACTED THE DIALYSIS NURSE (PDRN) FOR THIS HOME PATIENT(HP) WHO STATED THAT THE HP'S CAREGIVER HAD CONTACTED THE ON CALL PDRN ON (B)(6) 2010 TO REPORT CLOUDY PERITONEAL EFFLUENT. THE ON CALL PDRN INSTRUCTED THEM TO GO TO THE EMERGENCY ROOM. THE HP WAS HOSPITALIZED UNTIL THE MORNING OF (B)(6) 2010, WHEN SHE WAS DISCHARGED HOME. DURING HER HOSPITALIZATION, PERITONEAL DIALYSIS HAD BEEN WITHDRAWN FOR UNKNOWN REASONS. TREATMENT AND INTERVENTIONS RENDERED WERE NOT AVAILABLE. THE HP DIED THE NIGHT OF (B)(6) 2010 IN HER HOME OF UNKNOWN CAUSES AND WAS UNRELATED TO DIALYSIS SINCE PD THERAPY HAD NOT BEEN RESTARTED. PER THE PDRN, THE HUSBAND WAS THE HP'S CARETAKER AS SHE HAD BEEN BED BOUND FOR A QUITE SOMETIME. THE HUSBAND REPORTED THAT THE HP WAS TREATED FOR A URINARY TRACT INFECTION WHILE HOSPITALIZED. HE SAID THE DOCTORS BELIEVED THAT THIS WAS THE CAUSE OF THE PERITONITIS. IN 2007, THE HP STARTED PERITONEAL DIALYSIS USING PD4 AMBUFLEX (LOT, DOSE, AND FREQUENCY WAS NOT AVAILABLE) INTRAPERITONEALLY (IP). IT WAS UNKNOWN IF THE EVENT OF UTI OR PERITONITIS HAD RESOLVED PRIOR TO THE HP PASSING AWAY. THE PDRN COULD NOT GIVE CAUSALITY, BUT STATED THAT THE EVENT OF UTI, PERITONITIS OR DEATH WERE UNRELATED TO THE BAXTER PRODUCTS OR SOLUTIONS. THE PDRN INFORMED THAT FURTHER INFORMATION MAY BE AVAILABLE FROM THE HOSPITAL WHERE SHE WAS TREATED. BAXTER THEN ATTEMPTED TO GATHER INFORMATION FROM THE HOSPITAL'S RISK MANAGEMENT DEPT, BUT WAS TOLD THAT THEY WILL CALL BAXTER IF THAT INFORMATION COULD BE REVEALED.

    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 59 YR Hospitalization HOME CHOICE CYCLER| LOCAL PD4 ULTRABAG 1.5%| LOCAL PD4 AMBUFLEX