BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2892651 · Received January 2, 2013

    Report

    Report Number
    1416980-2013-00015
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 10, 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). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS: GD893305 AND GD893164. NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. THE PROBLEM WAS NOT CONFIRMED AND THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED.

    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. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION PROVIDED BY A NURSE IN THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPIES. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED BY THE CONSUMER. ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED ON THE SAME DAY OF THE EVENT. THE CAUSE OF THE PERITONITIS WAS REPORTED TO BE FIBERS WRAPPING AROUND THE CATHETER. THE PATIENT WAS SAID TO BE RECOVERING FROM THE PERITONITIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM A NURSE ON (B)(4) 2012. THE PATIENT WAS TREATED WITH VANCOMYCIN INTRAVENOUS (DOSAGE UNREPORTED) AND CEFEPIME (ROUTE AND DOSAGE UNREPORTED). ON (B)(6), THE PATIENT WAS DISCHARGED HOME WITH A PRESCRIPTION FOR GENTAMICIN INTRAPERITONEAL INJECTION (IP) FOR 7 DAYS. THE CAUSE OF THE PERITONITIS WAS BELIEVED BY THE NURSE TO BE CAUSED BY CONTAMINATION. THE PATIENT HAD A CAT THAT SLEPT IN THE BED WITH HER. THE NURSE WAS UNABLE TO CONFIRM OR CLARIFY THE CONSUMER REPORTED "FIBERS WRAPPING AROUND THE CATHETER." ON (B)(6) 2012, THE PATIENT DIED WHILE AT HOME. THE CAUSE OF DEATH WAS MYOCARDIAL INFARCTION. IT WAS UNKNOWN IF AN AUTOPSY WAS DONE. DIANEAL WAS ONGOING UNTIL DEATH. THE PATIENT WAS NOT HOOKED UP TO THE BAXTER HOMECHOICE MACHINE AT THE TIME OF DEATH. THE EVENTS WERE NOT RELATED TO DIANEAL SOLUTIONS, A BAXTER DEVICE, OR DISPOSABLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1794 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R DIANEAL PD4 AMBUFLEX