BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1822169 · Received September 1, 2010

    Report

    Report Number
    1423500-2010-03055
    Event Type
    Injury
    Date Received
    September 1, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 9, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS OPENED TO ADDRESS A PATIENT REACTION OF PERITONITIS. ROOT CAUSE FOR THE PERITONITIS WAS NOT IDENTIFIED DUE TO INSUFFICIENT INFORMATION AVAILABLE. SINCE NO SAMPLE WAS AVAILABLE FOR EVALUATION, NO ROOT CAUSE CAN BE DETERMINED THROUGH SAMPLE INSPECTION. NO SPECIFIC PRODUCT FAILURES WERE INDICATED IN THE COMPLAINT REPORT THAT COULD CONTRIBUTE TO PERITONITIS. SINCE THERE IS NOT ENOUGH INFORMATION TO DETERMINE ANY POSSIBLE PRODUCT FAILURE SOURCE, NO POTENTIAL CAUSES CAN BE LISTED. A BATCH REVIEW WAS PERFORMED FOR SUSPECT LOT NUMBERS, WITH NO DEFECTS NOTED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    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

    ON (B)(6) 2010 A DOCTOR REPORTED THAT A PATIENT LOST A SYBRONPRO XRT IMPLANT THREE (3) MONTHS AFTER PLACEMENT DUE TO UNKNOWN CAUSES. THIS IS THE SECOND OF TWO REPORTS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. 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. TREATMENT INFORMATION WAS NOT PROVIDED. PD THERAPY WAS ONGOING. THE PATIENT WAS RECOVERING FROM THE PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN.

    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 47 YR Hospitalization| R