BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 1971726 · Received January 27, 2011

    Report

    Report Number
    1423500-2011-01114
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 5, 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). THE SAMPLE IS NOT AVAILABLE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS NOT CONFIRMED DUE TO LACK OF SAMPLE AVAILABLE FOR EVALUATION. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. SINCE NO SAMPLE WAS AVAILABLE FOR EVALUATION AND NO PRODUCT MALFUNCTION IS ALLEGED, NO PRODUCT ROOT CAUSE IS EVIDENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THIS TO BE AN ISOLATED OCCURRENCE. BAXTER WILL CONTINUE TO MONITOR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THIS REPORT ADDRESSES REPORTED PRODUCT QUANTITY 2 OF 5. A BAXTER HOME CARE SERVICES REPRESENTATIVE CONTACTED BAXTER (B)(4) TO REPORT THAT A PATIENT STATED THAT WHEN HE ATTACHES THE MINICAP, SMALL BITS OF THE COTTON COME OFF AND BLOCK THE TUBE. THE PATIENT REPORTED THAT HE JUST HAD A NEW TRANSFER SET PUT ON. ON (B)(6) 2011 PRODUCT SURVEILLANCE SPOKE WITH THE HP WHO CONFIRMED THE REPORT THAT THE PIECES OF THE COTTON IN THE MINICAP WERE COMING OFF AND CLOGGING THE LINE. THE HP STATED HE TOOK THE MINICAPS TO THE CLINIC TO SHOW HIS NURSE (PDRN). THE HP STATED THAT ABOUT AN 1/8" OF THE COTTON WAS OFF THE INSIDE OF THE MINICAP. THE HP STATED THE PDRN LOOKED AT THE TRANSFER SET TUBING UNDER A MAGNIFYING GLASS AND FOUND THERE WAS A SHARP EDGE THAT COULD HAVE BEEN CAUSING THE PROBLEM. THE HP STATED HE HAD THE TRANSFER SET FOR ABOUT A WEEK OR TWO AND HAD PROBLEMS WITH ABOUT 4 OR 5 MINICAPS. THE HP STATED THEY CHANGED THE TRANSFER SET AND HE HAD NOT HAD A PROBLEM SINCE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS 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 GD879908

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR PERITONEAL DIALYSIS TRANSFER SET