BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2882572 · Received December 20, 2012

    Report

    Report Number
    1416980-2012-07881
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 27, 2012
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL SAMPLE WAS NOT AVAILABLE; HOWEVER, A COMPANION SAMPLE HAS BEEN REPORTED TO BE AVAILABLE AND REQUESTED FOR EVALUATION. THE COMPANION SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION AS OF YET. A BATCH REVIEW WAS CONDUCTED ON SUSPECT LOT GD893172,AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE REPORTED PROBLEM COULD NOT BE CONFIRMED, AS NO SAMPLES WERE RETURNED TO BAXTER FOR ANALYSIS. THEREFORE THE ROOT CAUSE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    AN EMAIL WAS RECEIVED FROM HOME CARE SERVICES REPRESENTATIVE (HCSR) RELAYING A REPORT FOR A HOME PATIENT (HP) WHO HAD A PACKAGING RELATED ISSUE WITH A MINICAP. THE HP STATED WHEN SHE TOOK THE MINICAP OUT OF THE BOX THE INDIVIDUAL POUCH SEEMED TO BE OPENED AND WHEN SHE TOOK THE MINICAP OUT OF THE PACKAGING IT APPEARED TO BE DRY. SHE ALSO STATED THERE WAS NO SOUND OF MOISTURE WHEN THE MINICAP WAS TWISTED OPEN. THERE WAS PATIENT INVOLVEMENT BUT NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. DURING A FOLLOW-UP WITH THE HOME PATIENT (HP), SHE STATED THERAPY IS GOING FINE AND REPORTED NO INJURY OR MEDICAL INTERVENTION.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR HOMECHOICE