BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2832188 · Received November 14, 2012

    Report

    Report Number
    1416980-2012-05106
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 11, 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). A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PROBLEM OF CONNECTION ISSUE WAS NOT CONFIRMED BECAUSE NO SAMPLES WERE RETURNED TO BAXTER FOR ANALYSIS. A ROOT CAUSE WAS NOT IDENTIFIED DUE TO INSUFFICIENT INFORMATION.

    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)(4) 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. NO ADDITIONAL INFORMATION WAS PROVIDED. ONE 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 GD892380

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR HOMECHOICE