BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIFUGAL PUMP HEADS

    MDR report key: 6079330 · Received November 4, 2016

    Report

    Report Number
    1124841-2016-00380
    Event Type
    Malfunction
    Date Received
    November 4, 2016
    Date of Event
    October 10, 2016
    Report Date
    December 19, 2016
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    KFM
    PMA / PMN Number
    K112229
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS SUBMITTED TO THE FDA IN ACCORD WITH APPLICABLE REGULATIONS - AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEM IN THE INITIAL REPORT SUBMITTED TO THE FDA ON NOVEMBER 4, 2016. UPON CONFIRMATION OF THE PHYSICAL SHIPMENTS OF THE AFFECTED PRODUCT, IT WAS FOUND THAT THE FOUR CASES THAT WERE SUPPOSED TO BE SHIPPED TO (B)(6)WERE MISTAKENLY SHIPPED TO (B)(6). ELECTRONICALLY, THE SHIPMENT WAS COMPLETED CORRECTLY; HOWEVER, THERE MUST HAVE BEEN AN ERROR IN SEGREGATION AT THE DISTRIBUTION CENTER. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    Description of Event or Problem · 1

    IT WAS REPORTED TO TERUMO CARDIOVASCULAR THAT THE CUSTOMER ONLY RECEIVED 8 CA AND NOT 12 CA AS PER THE PAPERWORK. THIS OCCURRED DURING OUT OF BOX. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729157 CENTRIFUGAL PUMP HEADS CENTRIFUGAL PUMP KFM TERUMO CARDIOVASCULAR SYSTEMS CORP. 164275 UH11

    Patients

    Seq Age Sex Outcome Treatment
    1