BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SX OXYGENATOR W/ HR (STERILE)

    MDR report key: 4834597 · Received June 8, 2015

    Report

    Report Number
    1124841-2015-00183
    Event Type
    Malfunction
    Date Received
    June 8, 2015
    Date of Event
    May 18, 2015
    Report Date
    July 29, 2015
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTZ
    PMA / PMN Number
    K130359
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS SUBMITTED TO THE FDA IN ACCORD WITH APPLICABLE REGULATIONS AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEMS ¿ AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEMS IN THE INITIAL REPORT SUBMITTED TO THE FDA ON JUNE 8, 2015. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: (B)(4). REVIEW OF ELECTRONIC RECORDS FOUND THAT THIS PACK WAS SHORT-DATED BECAUSE THE 3CXSX18R USED IN THE PACK WAS ORIGINALLY MANUFACTURED AS A LOW-VOLUME PART. IT WAS SUBSEQUENTLY REWORKED SO THAT IT COULD BE USED IN OTHER PACKS BEFORE EXPIRATION AND FOLLOWED THE FIRST-IN-FIRST-OUT INVENTORY PRINCIPLE. THE CUSTOMER, ACTING AS A DISTRIBUTOR, ENTERED INTO AN AGREEMENT WITH THEIR CUSTOMER FOR MINIMUM SHELF LIFE REQUIREMENTS. HOWEVER, TCVS WAS UNAWARE OF THESE REQUIREMENTS BECAUSE THERE WAS NO AGREEMENT IN PLACE FOR MINIMUM SHELF LIFE; THEREFORE, THE ROOT CAUSE WAS ATTRIBUTED TO CUSTOMER PREFERENCE. (B)(4). ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVAL; THEREFORE, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND MORE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORP THAT UPON REMOVING THE DEVICE FROM THE BOX, THE SHELF LIFE WAS FOUND TO BE EXPIRED. NO PT INVOLVEMENT AS THIS OCCURRED OUT OF BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367775 SX OXYGENATOR W/ HR (STERILE) BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORP. 3CXSX18R QH22A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA