BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1983802 · Received February 10, 2011

    Report

    Report Number
    1423500-2011-01734
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 19, 2011
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER

    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 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR 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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE. THIS IS A SPONTANEOUS REPORT BY A CONSUMER FROM (B)(6) OF DID NOT WEAR MASK AND REUSED EQUIPMENT-MINICAPS AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 UNKNOWN BAG THERAPY, INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON AN UNREPORTED DATE, THE PATIENT DID NOT WEAR A MASK AND REUSED EQUIPMENT-MINICAPS. ON (B)(6) 2011, PATIENT WAS DIAGNOSED WITH PERITONITIS (MANIFESTED BY PINEAPPLE JUICE-LIKE EFFLUENT AND ABDOMINAL PAIN) AND WAS HOSPITALIZED ON THE SAME DATE. ACTION TAKEN WITH DIANEAL PD2 UNKNOWN BAG WAS NOT REPORTED. ON AN UNREPORTED DATE, THE PATIENT RECEIVED REMEDIAL TREATMENT WITH CEFTAZIDIME 500 MG INTRAVENOUSLY (IV). AT THE TIME OF THIS REPORT, THE PATIENT REMAINED HOSPITALIZED WITH THE PERITONITIS ONGOING AND IMPROVED (RECOVERING). OUTCOME OF DID NOT WEAR A MASK AND REUSED EQUIPMENT WAS NOT REPORTED. THE REPORTER CONSIDERED THE EVENT OF PERITONITIS TO BE UNRELATED TO DIANEAL PD2 UNKNOWN BAG THERAPY. THE ROOT CAUSE OF THE PERITONITIS WAS REPORTED AS THE PATIENT DID NOT WEAR A MASK AND REUSED EQUIPMENT-MINICAPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R DIANEAL PD2 UNKNOWN BAG 1.5% (LOT: 10P064)| DIANEAL PD2 UNKNOWN BAG 4.25% (LOT: 10K064)