BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 4201594 · Received October 27, 2014

    Report

    Report Number
    1416980-2014-37471
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 26, 2014
    Report Date
    October 1, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THIS WAS DISCOVERED BY A NURSE, NOT PATIENT. EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS PERFORMED TO INVESTIGATE THE REPORTED ISSUE. A BATCH REVIEW WAS CONDUCTED ON LOT NUMBER 14A20H15 AND THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. A VISUAL INSPECTION WAS PERFORMED, AND IT WAS FOUND THAT THE FOAM WAS SEPARATED FROM THE MINICAP. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE WAS NOT DETERMINED. 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 DISLODGED IODINE SPONGE FROM THEIR MINICAP. THERE WAS NO PATIENT INVOLVEMENT, OR INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 2 OF 2 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683231 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - SWINFORD 14A20H15

    Patients

    Seq Age Sex Outcome Treatment
    1