BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI-CAP

    MDR report key: 2001310 · Received February 24, 2011

    Report

    Report Number
    1423500-2011-02443
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 3, 2011
    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). THIS IS REPORT 1 OF 3 ASSOCIATED WITH THIS PRODUCT. PER THE CUSTOMER THE SAMPLE WAS DISCARDED, THEREFORE NO EVALUATION COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR DAMAGED WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. A ROOT CAUSE WAS NOT IDENTIFIED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    DURING A CONFERENCE CALL WITH THE HOME PATIENT (HP) REGARDING THE CRACKED MINICAPS (THAT WERE REPORTED IN INITIAL EMDR #1423500-2011-00591), THE HP REVEALED THAT THREE ADDITIONAL MINICAPS WERE FOUND TO HAVE CRACKS. THE HP STATED THAT HE OBSERVED THE CRACKS IMMEDIATELY AFTER ATTACHING. THE HP STATED THAT HE DOES NOT ATTACH THE CAPS TOO TIGHTLY. THE CAPS REPORTEDLY JUST SEEMED TO BREAK. THE HP ALSO STATED THAT HE ALSO RUNS HIS FINGER AROUND THE BODY OF THE MINICAP TO SEE IF HE COULD "FEEL" A CRACK BEFORE PUTTING THEM ON. ACCORDING TO THE HP, THE MINICAPS DID NOT APPEAR TO BE CRACKED IN THE POUCH, AND HE HAD NOT SEEN ANYTHING IRREGULAR INSIDE THE POUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI-CAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD880757

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR