BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 4093879 · Received September 16, 2014

    Report

    Report Number
    1416980-2014-31608
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 22, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL SAMPLE WAS NOT RETURNED; A COMPANION SAMPLE WAS EVALUATED. THE MANUFACTURING DATES FOR THIS LOT ARE 11/14/13 TO 11/21/13. A COMPANION SAMPLE WAS RETURNED TO BAXTER HEALTHCARE FOR FURTHER INVESTIGATION. A VISUAL AND FUNCTIONAL (FLUID PRESSURE/LEAK) TEST WAS PERFORMED ON THE SAMPLE AND NO DEFECTS, OR NONCONFORMITIES WERE FOUND. A BATCH REVIEW WAS CONDUCTED ON LOT GD895953 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DISCONNECTION BETWEEN THEIR MINICAP AND THEIR TRANSFER SET DURING PERITONEAL DIALYSIS THERAPY. THE PATIENT WAS GIVEN UNKNOWN ANTIBIOTICS PROPHYLACTICALLY. HOWEVER, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571161 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD895953

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE