BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3213341 · Received July 9, 2013

    Report

    Report Number
    1416980-2013-17822
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 14, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBER H13C06089 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS CLARIFIED THAT THE PREVIOUS REPORT OF "THE CAP FELL OFF" WAS THE MINICAP FELL OFF. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(4) 2013, FOLLOW UP INFORMATION WAS OBTAINED RELATED TO THE EVENT. IT WAS REPORTED THAT THE CAUSE OF THE PERITONITIS WAS DUE TO AN UNSPECIFIED CAP FALLING OFF AND SUBSEQUENT BREAK IN ASEPTIC TECHNIQUE. THE PATIENT EXPERIENCED CLOUDY EFFLUENT AND ABDOMINAL PAIN AS A RESULT OF THE PERITONITIS. THE PATIENT'S CATHETER WAS REMOVED AND THE PATIENT WAS SWITCHED TO HEMODIALYSIS. IT WAS UNKNOWN IF THE PATIENT RECOVERED FROM THE EVENT. IT WAS NOT REPORTED IF THE PATIENT WAS RETRAINED ON ASEPTIC TECHNIQUE. AS A RESULT OF THE ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THE CASSETTE IS NO LONGER A SUSPECT PRODUCT IN THIS EVENT. BAXTER IS ATTEMPTING TO OBTAIN INFORMATION REGARDING THE SUSPECT PRODUCT. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 2 INVOLVED IN THIS EVENT. THIS IS A REPORT OF A PATIENT WHO EXPERIENCED AND WAS HOSPITALIZED FOR PERITONITIS COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS. THERAPY WAS DISCONTINUED. THE CAUSE OF THE EVENT WAS UNKNOWN AND TREATMENT INFORMATION WAS NOT REPORTED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TWO DAYS LATER. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313395 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization MINICAP, EXTRANEAL VIAFLEX| HOMECHOICE, DIANEAL PD4 ULTRABAG