BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3033185 · Received April 3, 2013

    Report

    Report Number
    1416980-2013-08248
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    February 1, 2013
    Report Date
    March 14, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    BRZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF OTHER ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. THE REPORTED CONDITION WAS CONFIRMED DURING EVALUATION. A VISUAL EXAMINATION OF THE SAMPLE SHOWED SIGNS OF, WHAT LOOKED LIKE, EXCESS SOLVENT INSIDE OF THE TUBING. HOWEVER, UPON FURTHER MICROSCOPIC EXAMINATION, IT WAS DETERMINED THAT THERE WAS NOT EXCESS SOLVENT, BUT CRIMPED TUBING INSIDE OF THE TUBING. PRESSURE TESTING WAS PERFORMED AND INDICATED A BLOCKAGE IN THE FLUID PATHWAY. THE CAUSE OF THE REPORTED CONDITION WAS DETERMINED TO BE AN OPERATOR ERROR DURING THE MANUFACTURING PROCESS. AWARENESS TRAINING WAS PERFORMED WITH THE OPERATORS IN ORDER TO ADDRESS THIS ISSUE. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. THE BATCH REVIEW REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. THERE WERE NO NON-CONFORMANCES, FAILURES, REWORK, OR DEVIATIONS RELATED TO THE LOT. THERE WERE NO CHANGES TO SPECIFICATIONS, TEST METHODS, PROCESS, EQUIPMENT, OR RAW MATERIALS THAT COULD BE ASSOCIATED WITH THE REPORTED CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE TUBING OF A Y-TYPE BLOOD/SOLN SET WITH STANDARD BLOOD FILTER 170-260 MICRON FILTER, MALE LUER LOCK ADAPTER 10 DPM WOULD NOT FLUSH BEYOND THE FILTER. THE CONDITION OCCURRED DURING PRIMING. THERE IS NO REPORT OF PATIENT INVOLVEMENT, INJURY/ADVERSE EVENTS, OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136652 ACCESS SET, BLOOD TRANSFUSION BRZ BAXTER HEALTHCARE - AIBONITO UR12K02075

    Patients

    Seq Age Sex Outcome Treatment
    1