BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP

    MDR report key: 2944132 · Received February 5, 2013

    Report

    Report Number
    1416980-2013-02967
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 15, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROBLEM WAS NOT CONFIRMED AND THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. A BATCH REVIEW WAS PERFORMED, AND NO ISSUES WERE DETECTED DURING THE MANUFACTURING OF POTENTIALLY ASSOCIATED LOT GD893305.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 2 OF 3 INVOLVED IN THIS EVENT.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A REPORT FROM A CONSUMER IN THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL AND EXTRANEAL THERAPIES. ON UNREPORTED DATES, THE PATIENT EXPERIENCED AN EXTREME AMOUNT OF ABDOMINAL PAIN WHILE DRAINING AND FILLING. SOMETIME LAST MONTH (DATE NOT SPECIFIED), THE PATIENT EXPERIENCED CLOUDY PERITONEAL EFFLUENT DURING HIS DAY DRAIN. THE PATIENT TOOK A SAMPLE FROM THIS DAY DRAIN AND BROUGHT IT WITH HIM TO THE CLINIC. PER THE PATIENT, TWO WEEKS AGO, HE HAD DEVELOPED PERITONITIS. PERITONITIS WAS TREATED WITH VANCOMYCIN INTRAPERITONEAL, 2 VIALS EACH TIME (FREQUENCY NOT REPORTED), ADMINISTERED IN THE CLINIC. CAUSE OF PERITONITIS WAS NOT REPORTED. IT WAS NOT REPORTED IF RETRAINING ON ASEPTIC TECHNIQUE WAS PERFORMED. AT THE TIME OF THIS REPORT, THE EXTREME AMOUNT OF ABDOMINAL PAIN WAS RESOLVING. THE OUTCOME OF PERITONITIS WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT'S PERITONEAL EFFLUENT WAS CLEAR. THE PATIENT PROVIDED VERBAL CONSENT TO CONTACT HIS NURSE FOR FURTHER INFORMATION. NO FURTHER INFORMATION WAS PROVIDED DURING THIS CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48606 MINI-CAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention DIANEAL AND EXTRANEAL