BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2862821 · Received December 10, 2012

    Report

    Report Number
    1416980-2012-06760
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 14, 2012
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE REPORTED CONDITION COULD NOT BE CONFIRMED AND A ROOT CAUSE COULD NOT BE IDENTIFIED BECAUSE A SAMPLE WAS NOT RETURNED TO BAXTER FOR EVALUATION. CORRECTION: CLARIFICATION OF INFORMATION PROVIDED IN THE INITIAL MEDWATCH: THE CAREGIVER REPORTED A TOTAL QUANTITY OF 20 MINICAPS IN WHICH THE IODINE WAS DRIED UP. THIS REPORT REPRESENTS MINICAP 12 OF 20.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A RENAL HOME PATIENT'S (HP) CAREGIVER (CG) CONTACTED BAXTER RENAL HOME CARE SERVICES CONCERNING 20 MINICAPS IN WHICH THE IODINE WAS DRIED UP. THE CG SAID THE SPONGE DID NOT SEEM MOIST INSIDE THE CAP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THERE WAS PATIENT INVOLVEMENT. BAXTER PRODUCT SURVEILLANCE CONTACTED THE CAREGIVER (CG) ON (B)(6) 2012 REGARDING THE DRIED UP MINICAPS. THE CG SAID SHE DID NOT SEE ANY DAMAGE TO THE MINICAP POUCHES NOR WERE THE POUCHES OPEN PRIOR TO USE. THE CG SAID THAT SHE STUCK HER FINGER DOWN INSIDE THE CAPS AND THEIR SPONGES FELT DRY. THE CG SAID THAT SHE HAD DISCARDED THE SAMPLES. THE CG SAID SHE WOULD CALL IF SHE FOUND ANYMORE THAT WERE DRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD893149

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR TRANSFER SET