BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2212737 · Received August 16, 2011

    Report

    Report Number
    1423500-2011-10753
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 27, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS IS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNLIKELY THAT A DEVICE DEFECT AND/OR MALFUNCTION CAUSED THIS PERITONITIS. THE PATIENT?S HEALTHCARE PROVIDER REPORTED A BREAK IN ASEPTIC TECHNIQUE AS THE PROXIMATE CAUSE OF THE EVENT AND THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE USER ERROR.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A PHYSICIAN FROM THE (B)(6) OF A BREAK IN ASEPTIC TECHNIQUE AND BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR E. COLI IN A PATIENT COINCIDENT WITH DIANEAL PD2 UNKNOWN BAG THERAPY FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). IN 2011, A BREAK IN ASEPTIC TECHNIQUE OCCURRED. ON (B)(6) 2011, THE PATIENT EXPERIENCED BACTERIAL PERITONITIS, MANIFESTED BY CLOUDY DIALYSATE AND ABDOMINAL PAIN. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR THE BACTERIAL PERITONITIS. REMEDIAL TREATMENT INCLUDED AMIKACIN (12.5 MG/L IN PD SOLUTION). THE OUTCOMES OF THE BACTERIAL PERITONITIS AND THE BREAK IN ASEPTIC TECHNIQUE WERE NOT REPORTED. THE ACTION TAKEN WITH DIANEAL WAS NOT REPORTED. THE REPORTER DID NOT PROVIDE AN ASSESSMENT OF CAUSALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R DIANEAL PD2 UNKNOWN BAG