BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3003994 · Received March 14, 2013

    Report

    Report Number
    1416980-2013-06108
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 20, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). DUE TO THE INFORMATION RECEIVED, IT WAS DETERMINED THAT A BREACH IN ASEPTIC TECHNIQUE WAS THE CAUSE OF THE PERITONITIS. AS A RESULT, THE MINI CAP IS NO LONGER A SUSPECT PRODUCT. ALL FURTHER INVESTIGATIONS OF THIS EVENT WILL BE DOCUMENTED IN REPORT NUMBER 1416980-2013-06106.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS: GD893560 AND GD893446. NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. 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

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED FOR THIS EVENT. TREATMENT INCLUDED VANCOMYCIN, INTRA-PERITONEALLY (DOSE AND FREQUENCY NOT KNOWN). THE PATIENT'S CATHETER WAS REMOVED AND THE PATIENT BEGAN HEMODIALYSIS. AT THE TIME OF THIS REPORT, THE PATIENT WAS STILL HOSPITALIZED BUT RECOVERING FROM THIS PERITONITIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107091 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R DIANEAL PD2 AMBUFLEX