BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1790531 · Received August 10, 2010

    Report

    Report Number
    1423500-2010-02327
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 19, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ROOT CAUSE WAS UNDETERMINED. A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS: GD872911, GD873927 AND GD874859 WITH NO DEVIATIONS FROM STANDARD PROCEDURE. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THIS IS THE SECOND COMPLAINT OF THREE ASSOCIATED WITH THIS COMPLAINT.

    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.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM (B)(6) OF PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) IN A PATIENT WHILE RECEIVING PERITONEAL DIALYSIS (PD) THERAPY. THIS CASE WAS INITIALLY RECEIVED BY BAXTER CUSTOMER SERVICE FROM THE CONSUMER. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS MANIFESTED BY CLOUDY EFFLUENT AND SEVERE ABDOMINAL PAIN. ON THE SAME DATE, THE PATIENT WAS HOSPITALIZED. ON AN UNREPORTED DATE, THE PATIENT STARTED THERAPY WITH VANCOMYCIN, CEFTAZIDIME AND MEROPENEM (DOSE, ROUTE AND FREQUENCY WERE NOT REPORTED) FOR PERITONITIS. ON (B)(6) 2010, THE PATIENT WAS RELEASED FROM THE HOSPITAL. AUTOMATED PD TREATMENT REMAINED UNCHANGED. THE NURSE REPORTED THAT THE PATIENT DOES NOT REUSE SOLUTIONS AND IT WAS UNKNOWN IF THERE WAS BREAK IN ASEPTIC TECHNIQUE. THE PATIENT HAD NO CATHETER INFECTION OR PREVIOUS PERITONITIS EPISODES IN THE LAST 4 WEEKS. THE NURSE REPORTED THAT THE PATIENT WAS RECOVERING AT THE TIME OF THIS REPORT. THE REPORTING NURSE CONSIDERED THE EVENT OF PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) TO BE UNRELATED TO EXTRANEAL AND PHYSIONEAL VIAFLEX THERAPIES.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF PERITONITIS IN A (B)(6) FEMALE PATIENT COINCIDENT WITH HOMECHOICE PERITONEAL DIALYSIS THERAPY. ON (B)(6) 2010, DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE REPORTING NURSE STATED THAT ON (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS AND WAS HOSPITALIZED THE SAME DAY. IT WAS UNKNOWN WHETHER A PERITONEAL EFFLUENT CULTURE WAS PERFORMED. TREATMENT INFORMATION WAS NOT PROVIDED. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED; HOWEVER WHEN THE NURSE WAS ASKED WHAT THE CAUSE OF THE PERITONITIS WAS DUE TO, THE NURSE REPLIED THAT THE PATIENT WAS BEING CARED FOR BY A NURSING HOME STAFF. IT WAS UNKNOWN WHETHER THE PERITONITIS RESOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R 1.5% LO/CAL UB 2.5L/3L DIANEAL, 1.5% LO/CAL 6L DIA