BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2832007 · Received November 14, 2012

    Report

    Report Number
    1416980-2012-05090
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 23, 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). ADDITIONAL COMPANION SAMPLE WAS RETURNED AND EVALUATED. THE REPORTED PROBLEM OF CONNECTION ISSUE WAS NOT CONFIRMED. FOLLOWING VISUAL EXAMINATION AND PRESSURE TESTING, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. A ROOT CAUSE WAS NOT IDENTIFIED DUE TO INSUFFICIENT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED PROBLEM WAS NOT CONFIRMED. A COMPANION SAMPLE WAS RETURNED TO BAXTER; FOLLOWING VISUAL EXAMINATION AND PRESSURE TESTING, THE REPORTED CONDITION COULD NOT BE CONFIRMED. A ROOT CAUSE WAS NOT IDENTIFIED.

    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. THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE CAREGIVER (CG) CONTACTED PRODUCT SURVEILLANCE TO REPORT LOOSE MINICAPS ON (B)(6) 2012. THE CG STATED THAT THE HOME PATIENT (HP) WENT TO THE CLINIC ON (B)(6) 2012, TO HAVE HIS 6 MONTH TRANSFER SET CHANGED OUT. THE CG SAID THAT WHEN THE HP WENT TO REMOVE THE MINICAP FOR THERAPY THAT NIGHT IT WAS LOOSE. THE HP TRIED 2 DIFFERENT LOT NUMBERS AND SOME FROM THE CLINIC. THE CG SAID THE HP WENT TO THE CLINIC ON (B)(6) 2012, TO HAVE THE TRANSFER SET CHANGED OUT AGAIN. THE HP REPORTED THAT EVERY NIGHT BETWEEN (B)(6) 2012 THAT THE MINICAPS WERE STILL LOOSE. THE CG SAID THAT THE MINICAPS STILL APPEAR TO BE LOOSE ON THE NEW TRANSFER SET. THE CG SAID THAT SHE WOULD RETURN A MINICAP FROM BOTH REPORTED LOT NUMBERS AND A MINICAP FROM THE CLINIC (IF SHE COULD FIND ONE). NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THERE WAS PATIENT INVOLVEMENT. 6 OF 13 MINICAP - CONNECTION ISSUE.

    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 GD892968

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR HOMECHOICE