BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2786057 · Received October 12, 2012

    Report

    Report Number
    1416980-2012-02273
    Event Type
    Malfunction
    Date Received
    October 12, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 20, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE CANNOT BE DETERMINED. SINCE THE PRODUCT CODE AND LOT NUMBER OF THE DEVICE INVOLVED ARE UNKNOWN, A 510K NUMBER CANNOT BE PROVIDED AND A BATCH REVIEW CANNOT BE PERFORMED. IF THE SAMPLE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED FOR EVALUATION; HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF EVALUATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE. UPON THE CUSTOMER'S RETURNED SAMPLE, IT WAS NOTED THAT THE PRIMARY IV SET IS BAXTER CLEARLINK CONTINU-FLO SOLUTION SET, PRODUCT CODE (B)(4) (510K K961225) AND THE SECONDARY MEDICATION SET IS BAXTER PRODUCT CODE (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ACTUAL USED SAMPLE WAS RETURNED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED CONDITION WAS NOT CONFIRMED. THE ROOT CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE ONE PRIMARY IV TUBING SET IN WHICH A SIMULTANEOUS FLOW WAS DETECTED DURING A SECONDARY INFUSION OF UNKNOWN RATE AFTER AN UNKNOWN DURATION OF TIME WITH A SIGMA SPECTRUM PUMP. PER THE REPORT, THE PRIMARY BAG CONTAINING 500ML OF 0.9% NORMAL SALINE WAS LOWERED 12.5 INCHES BELOW THE SECONDARY 50ML BAG OF (B)(4) PREMIX CEFTRIAXONE AND DEXTROSE. THE SECONDARY TUBING WAS CONNECTED TO THE PRIMARY TUBING AT THE UPPER Y-SITE. THE CUSTOMER DOES NOT KNOW IF THE BACK CHECK VALVE WAS INVERTED AND TAPPED ON THE PRIMARY TUBING DURING PRIMING PER LABEL COPY. IT IS UNKNOWN IF THE PRIMARY LINE WAS CLAMPED WHEN THE SIMULTANEOUS FLOW WAS OBSERVED. THERE IS PATIENT INVOLVEMENT; HOWEVER, THERE IS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 SIGMA SPECTRUM PUMP (SERIAL NUMBER (B)(4))| SECONDARY MEDICATION SET ((B)(4))| B BRAUN CEFT & DEXT ((B)(4), LOT H2D742) 50ML| 0.9% NORMAL SALINE ((B)(4), LOT C875138) 500ML| UNKNOWN SECONDARY MEDICATION SET