BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1955436 · Received January 10, 2011

    Report

    Report Number
    1423500-2011-00383
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 18, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    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. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION. THIS IS THE SECOND OF TWO REPORTS ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD878843 AND GD879189 WITH NO DEFECTS NOTED. ROOT CAUSE COULD NOT BE DETERMINED BASED ON INFORMATION AVAILABLE IN THIS COMPLAINT REPORT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THIS IS THE SECOND OF TWO REPORTS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    DURING A PHONE CALL FOR AN UNRELATED ALARM, A HOME PATIENT (HP) REPORTED SHE WAS USING MEDICATED BAGS OF INTRAPERITONEAL (IP) SOLUTION FOR PERITONITIS. ON (B)(6) 2010 BAXTER CONTACTED A NURSE(RN) AT THE HP'S DIALYSIS CLINIC WHO REVEALED THAT ON (B)(6) 2010, THE HP COMPLAINED OF ABDOMINAL PAIN AND CLOUDY PERITONEAL EFFLUENT, AND WAS INSTRUCTED TO COME TO THE DIALYSIS CLINIC. AFTER PERITONITIS WAS CONFIRMED, VANCOMYCIN 3GM AND CEFTAZIDINE(NO DOSE GIVEN) IP WAS INITIALLY GIVEN (DURATION UNREPORTED). ON (B)(6) 2010, THE HP WAS HOSPITALIZED AND TREATED WITH INTRAVENOUSLY (IV)ANTIBIOTICS (DRUG AND DOSE NOT REPORTED). THE RN STATED THE CAUSALITY WAS LIKELY DUE TO AN ACUTE BOUT OF CONSTIPATION THAT THE HP EXPERIENCED FOR A NUMBER OF DAYS PRIOR TO SYMPTOM ONSET. AT THE TIME OF THE REPORT, SHE REMAINED HOSPITALIZED. THE RN DID NOT KNOW IF THIS WAS DUE TO COMPLICATIONS OF THE CONSTIPATION, PERITONITIS OR ANOTHER PROBLEM. THE RN ADDED THAT NONE OF THE BAXTER PRODUCTS OR SOLUTIONS WERE SUSPECT. THE HP HAS RECEIVED AUTOMATED PERITONEAL DIALYSIS (APD) WITH AMBUFLEX LOCAL PD4 SOLUTION FOR AN UNREPORTED DURATION AND WILL CONTINUE WITH THIS TREATMENT AFTER 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 75 YR Hospitalization| R HOME CHOICE CYCLER| AMBUFLEX LOCAL PD4