BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2941429 · Received February 4, 2013

    Report

    Report Number
    1416980-2013-02752
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 14, 2013
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROBLEM WAS NOT CONFIRMED AND A ROOT CAUSE COULD NOT BE IDENTIFIED. AN EVALUATION OF THE ACTUAL SAMPLE POUCH WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE EVALUATION. THE POUCH RECEIVED WAS EMPTY AND HAD A MARK ON IT INDICATING WHERE THE PATIENT PERCEIVED THERE WAS A HOLE. THE SAMPLE WAS HELD UP TO A LIGHT SOURCE AND NO LIGHT PENETRATION OF THE POUCH WAS NOTED AND THERE WAS NO IODINE STAINING ON THE OUTSIDE OF THE POUCH. AN EVALUATION WAS PERFORMED WHEREBY IODINE WAS PLACED DIRECTLY ON THE INNER SURFACE OF THE POUCH AT THE LOCATION WHERE IT HAD BEEN INDICATED THERE WAS A HOLE. THE IODINE DID NOT PENETRATE TO THE OUTER SURFACE OF THE POUCH. THE SAMPLE WAS VISUALLY INSPECTED BY USING AN OPTICAL COMPARATOR WITH (B)(4) MAGNIFICATION. NO LIGHT PENETRATION WAS NOTED (NO HOLE DETECTED). THE SAMPLE RECEIVED SHOWED STRONG EVIDENCE OF EXCESSIVE HANDLING. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER.

    Description of Event or Problem · 1

    A COMPLAINT WAS REPORTED BY A NURSE, ON BEHALF OF A PATIENT, TO BAXTER (B)(4) INVOLVING A MINICAP'S WRAPPER THAT WHEN THE PATIENT HELD UP THE DEVICE'S OPEN WRAPPER TO THE LIGHT, HE COULD SEE SMALL, LIGHT HOLES. THE PATIENT CONFIRMED THE MINICAP'S SPONGE WAS NOT DRY. THERE WAS PATIENT INVOLVEMENT BUT NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46815 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - SWINFORD 12I06H15

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR HOMECHOICE