BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2822162 · Received November 7, 2012

    Report

    Report Number
    1416980-2012-04249
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 21, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PROBLEM OF CONNECTION ISSUE WAS NOT CONFIRMED. THE ROOT CAUSE WAS NOT DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAD BEEN DISCARDED AND THE LOT NUMBER WAS UNKNOWN, A BATCH REVIEW COULD NOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE FILED. THE REPORTED ISSUE WAS NOT CONFIRMED. THE DEVICE WAS NOT RETURNED TO BAXTER, PRECLUDING FURTHER DEVICE INVESTIGATION. AS A RESULT, AN ASSIGNABLE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. THE LOT NUMBER IS KNOWN AND A BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL SAMPLE WAS NOT RETURNED, HOWEVER A COMPANION SAMPLE WAS RETURNED. ADDITIONAL INFORMATION: THE REPORTED PROBLEM OF CONNECTION ISSUE WAS NOT CONFIRMED. A COMPANION SAMPLE WAS RETURNED TO BAXTER. A VISUAL EXAMINATION AND PRESSURE TESTING WERE PERFORMED, HOWEVER, THE REPORTED CONDITION COULD NOT BE CONFIRMED. THEREFORE, THE ROOT CAUSE COULD NOT BE IDENTIFIED. PER REVIEW OF THE BATCH RECORDS, NO NONCONFORMANCE REPORT WAS DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT.

    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 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. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT'S (HP) REGISTERED NURSE (RN) ON (B)(6) 2012 REGARDING THE LOOSE MINICAPS. THE RN SAID THAT SHE HAD DISCARDED THE TRANSFER SET THAT SHE HAD CHANGED OUT. THE RN AGREED TO CHANGE OUT THE HP'S TRANSFER SET AGAIN AND RETURN THIS ONE FOR EVALUATION. THE RN DID NOT HAVE A LOT NUMBER. THE RN DID NOT HAVE ANY OF THE MINICAPS TO RETURN. NO ADDITIONAL INFORMATION WAS PROVIDED; 11 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 GD892646

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR HOMECHOICE