BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2821710 · Received November 6, 2012

    Report

    Report Number
    1416980-2012-04226
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 12, 2012
    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). 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 3 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD892828 AND GD892646 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. THE PROBLEM WAS NOT CONFIRMED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. NO ASSIGNABLE CAUSE WAS DETERMINED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT FROM A CONSUMER, WITH SUPPLEMENTAL INFORMATION PROVIDED BY A NURSE, IN THE USA. THIS REPORT IS OF BLADDER RETENTION, CONTAMINATION DUE TO THE PLACEMENT OF A FOLEY CATHETER THAT TRAVELLED UP, AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPIES FOR PERITONEAL DIALYSIS (PD). DIANEAL THERAPIES WERE ONGOING. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED BLADDER RETENTION. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR THE BLADDER RETENTION AND AN INFECTION. THE NURSE FURTHER CLARIFIED THAT THE INFECTION WAS PERITONITIS. ON THAT SAME DAY, THE PATIENT WENT TO THE EMERGENCY ROOM TO HAVE A FOLEY CATHETER PLACED FOR THE BLADDER RETENTION. THE PATIENT WAS PERFORMING DAILY STRAIGHT CATHETERIZATIONS AS A TREATMENT FOR THE BLADDER RETENTION. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED CONTAMINATION DUE TO THE PLACEMENT OF THE FOLEY CATHETER THAT TRAVELLED UP. PER THE NURSE, THIS MAY HAVE CONTRIBUTED TO THE PERITONITIS. THE PATIENT WAS TREATED WITH VANCOMYCIN AND FORTAZ FOR THE PERITONITIS. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS. THE PATIENT HAD NOT YET RECOVERED FROM THE BLADDER RETENTION. THE OUTCOME FOR THE CONTAMINATION, CAUSED BY THE PLACEMENT OF THE FOLEY CATHETER THAT TRAVELLED UP, WAS NOT REPORTED. PER THE NURSE, THE EVENTS WERE UNRELATED TO DIANEAL THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Hospitalization| R DIANEAL PD4 AMBUFLEX| HOMECHOICE