BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3971593 · Received July 31, 2014

    Report

    Report Number
    1416980-2014-24885
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    June 13, 2014
    Report Date
    July 7, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DEVICE WAS NOT RETURNED, A DEVICE ANALYSIS COULD NOT BE COMPLETED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER(S) GD896589 AND GD896407 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS IS SAME PATIENT AS IN (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED FUNGAL PERITONITIS COINCIDENT WITH AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY. THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON THE SAME DAY AS THE ONSET, THE PATIENT WAS HOSPITALIZED WITH AN UNRELATED ADMITTING DIAGNOSIS AND THEN WAS LATER DIAGNOSED WITH PERITONITIS WHILE STILL BEING HOSPITALIZED. THE TREATMENT FOR THE PERITONITIS EVENT WAS NOT REPORTED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL SEVEN DAYS LATER. THE OUTCOME OF THE PERITONITIS WAS UNKNOWN. THE FOLLOWING MONTH AFTER THE ONSET OF PERITONITIS, THE PD THERAPY WAS DISCONTINUED AND THE PD CATHETER WAS REMOVED. THE PATIENT BEGAN HEMODIALYSIS. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THIS TIME. THIS IS REPORT 2 OF 3 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448178 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization DIANEAL 1.5% AND 2.5% PD4 AMBUFLEX, HOMECHOICE| MINICAP TRANSFER SET, EXTRANEAL VIAFLEX| HOMECHOICE AUTOMATED PD SET WITH CASSETTE