BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIRD

    MDR report key: 2170747 · Received June 22, 2011

    Report

    Report Number
    2021710-2011-00042
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Report Date
    May 6, 2011
    Manufacturer
    CAREFUSION
    Product Code
    BZR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). NEITHER THE FOREIGN USER FACILITY NOR THE FOREIGN DISTRIBUTOR SUBMITTED A USER FACILITY/IMPORTER REPORT TO THE MFR. (B)(4). THE CAREFUSION FAILURE ANALYSIS LAB TECH EVALUATED THE MICROBLENDER, VERIFIED THE COMPLAINT AND DETERMINED THAT THE ROOT CAUSE OF THE FAILURE WAS THAT THE REED ON THE ALARM REED PLATE WAS CRACKED. THE CAREFUSION FAILURE ANALYSIS LAB TECH WAS UNABLE TO DETERMINE THE CAUSE OF THE DAMAGE TO THE REED. HOWEVER, THIS TYPE OF DAMAGE IS GENERALLY CAUSED BY THE APPLICATION OF A MECHANICAL FORCE OR PRESSURE AGAINST THE REED ON THE ALARM REED PLATE. THE MICROBLENDER WILL BE ROUTED TO THE CAREFUSION FACTORY SVC DEPT TO BE REPAIRED AND RUN THROUGH A COMPLETE CALIBRATION AND CHECKOUT TO ENSURE THAT IT MEETS ALL FACTORY SPECIFICATIONS. UPON COMPLETION THE MICROBLENDER WILL BE RETURNED TO THE DISTRIBUTOR IN (B)(6) READY TO BE RETURNED TO THEIR CUSTOMER READY TO BE PLACED BACK INTO SVC. A REVIEW OF THE CAREFUSION COMPLAINT SYSTEM FOR THE PAST 90 DAYS DID FIND ONE VERIFIED LIKE FAILURE WITH THE SAME ROOT CAUSE. HOWEVER, AS THESE ARE KNOWN FAILURES CAUSED OR CONTRIBUTED TO BY AN UNAPPROVED MEANS OF FORCE OR PRESSURE, ANOTHER INVESTIGATION IS NOT REQUIRED.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM AN E-MAIL FROM THE FOREIGN DISTRIBUTOR IN (B)(6). "BOTH THE BLENDERS HAVE FAILED DURING THE LAST TWO DAYS, BOTH IN A DANGEROUS MANNER IN THAT THEY WERE DELIVERING 100% OXYGEN WHILE SET FOR 31% AND BOTH FAILED TO ALARM." THE FOLLOWING ADDITIONAL INFO CONCERNING THE EVENT WAS COPIED FROM AN E-MAIL FROM CAREFUSION (B)(6) THAT WAS IN RESPONSE TO AN E-MAIL SENT BY CAREFUSION ASKING THAT THEY SEEK ADDITIONAL INFO FROM THE FOREIGN DISTRIBUTOR IN (B)(6). "THE BLENDERS WERE SET 21%, BUT AS AIR CYLINDER WAS EMPTY THE ALARM FAILED AND THE BLENDER CONTINUED TO DELIVER 6 LPM OF 100% OXYGEN RATHER THAN 21%. THE C SIZE AIR CYLINDER HAD RUN OUT OF GAS, THOUGH THE WALL OXYGEN WAS STILL CONNECTED. THE BLENDER WAS SET TO 21%. NO PT WAS ATTACHED AT THE TIME; THE MATERNITY STAFF WERE TESTING THE UNIT PRIOR TO USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIRD MIXER, BREATHING GASES, ANESTHESIA INHALATION / BZR BZR CAREFUSION MICROBLENDER NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA