BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI-CAP

    MDR report key: 2104755 · Received May 27, 2011

    Report

    Report Number
    1423500-2011-06624
    Event Type
    Malfunction
    Date Received
    May 27, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 9, 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 HAS BEEN RECEIVED, AND THE EVALUATION IS IN PROCESS. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR AN INADEQUATE IODINE WAS NOT CONFIRMED IN THE LAB. THE RESULTS OF A SAMPLE EVALUATION DID NOT REVEAL ANY MANUFACTURING ABNORMALITIES. A ROOT CAUSE WAS NOT IDENTIFIED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. 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

    EMAIL RECEIVED IN CORPORATE MAILBOX ON (B)(4) 2011. PATIENT REPORTED RECEIVING A BUNCH OF MINICAPS THAT WERE ALREADY "DRIED OUT." ALSO 5C4527 CLAMPS BREAK VERY EASILY. THIS IS 9 OF 12 MINI CAPS REPORTED. PRODUCT SURVEILLANCE CONTACTED THE PATIENT ON (B)(4) 2011. THE PATIENT STATED THE FOLLOWING: "THERE WAS ABOUT 10-12 CAPS AFFECTED AND THEY WERE RETURNED TO THE NURSE." THE REST OF THE BOX "WAS USED AND THE NEW BOX HAS NO ISSUES. THERE WAS ABOUT 2-3 CLAMPS THAT WERE HAVING THE ISSUE OF BREAKING." THE SAMPLES WERE DISCARDED AND LOT NUMBERS UNKNOWN. THE NEW BOX OF CLAMPS IS WORKING FINE. THE PATIENT WAS INVOLVED BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. PRODUCT SURVEILLANCE CONTACTED THE NURSE ON (B)(4) 2011. THE NURSE STATED THE FOLLOWING: "THE SAMPLES ARE STILL AVAILABLE AND THE SPONGES WERE A LITTLE PULLED OUT WITH NO SOLUTION ON THE TOP BUT THEY WERE WET WITH IODINE ON THE BOTTOM." THE NURSE STATED THE PATIENT HAS VISION ISSUES AND "PROBABLY JUST COULDN'T SEE THE IODINE AT THE BOTTOM OF THE SPONGE." NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 GD883942

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR