BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2182773 · Received July 28, 2011

    Report

    Report Number
    1423500-2011-09907
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 7, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT FOR A CONNECTION ISSUE WAS NOT CONFIRMED. COMPANION SAMPLES WERE EVALUATED. THE ROOT CAUSE WAS UNDETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. A LABELING REVIEW FOUND THE LABELING TO BE ADEQUATE FOR THE POTENTIAL USE/USER ERROR IN THIS INCIDENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THIS TO BE AN ISOLATED OCCURRENCE. BAXTER WILL CONTINUE TO MONITOR THIS PRODUCT FOR ADVERSE TRENDS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WILL BE PERFORMED FOR THE LOT NUMBER PROVIDED. A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    CORPORATE PRODUCT SURVEILLANCE (CPS) RECEIVED A REPORT THAT A QUANTITY OF FOUR MINI CAPS FOR ONE HOME PATIENT (HP) HAD BECOME LOOSE AND FALLEN OFF WHILE IN USE. THIS REPORT ADDRESSES INCIDENT 4 OF 4. PRODUCT SURVEILLANCE (PS) SPOKE WITH THE HP'S NURSE. THE NURSE SAID THAT THE CAPS FELL OFF AN UNKNOWN NUMBER OF TIMES WITHIN THE LAST COUPLE OF WEEKS OR MONTHS. THE NURSE SAID SHE WATCHED THE HP CONNECT THE CAP TO THE TRANSFER SET, AND SHE SAID SHE DID NOT SEE HIM DO ANYTHING WRONG. THE CG SAID THEY LATER REALIZED THE HP WAS DOING PHYSICAL ACTIVITY AT THE TIME OF THE INCIDENT. THE HP WAS LEAVING THE TRANSFER SET HANGING AND IT WAS RUBBING ON HIS SHORTS AS HE WAS BENDING DOWN AND STANDING UP IN THE YARD WHILE IT WAS HOT OUTSIDE. THE CG SAID THEY DID NOT THINK IT WAS A PROBLEM WITH THE SUPPLIES. THE HP SAID NO CAPS HAD FALLEN OFF SINCE HE STARTED USING A NEW BOX. THE HP SAID HE THOUGHT IT WAS BECAUSE HIS WIFE SEWED A POCKET INTO HIS SHORTS TO PROTECT THE TRANSFER SET. THE PATIENT WAS INVOLVED BUT THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    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 GD884445

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR