BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFLOW 16G IV PORT INTER

    MDR report key: 9167769 · Received October 8, 2019

    Report

    Report Number
    3006260740-2019-02936
    Event Type
    Malfunction
    Date Received
    October 8, 2019
    Date of Event
    August 6, 2019
    Report Date
    October 8, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    PTD
    UDI-DI
    00801741129438
    PMA / PMN Number
    K163001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A MANUFACTURING REVIEW COULD NOT BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. JOURNAL ARTICLE CITATION: GARRITY, D., GRAVES, M., LINDEN, J., PIERRE, P. S., DUCHARME, P., ZHAO, Y., ¿ WEINSTEIN, R. (2019). PERFORMANCE CHARACTERISTICS OF THE POWERFLOW APHERESIS PORT: EARLY EXPERIENCE. JOURNAL OF CLINICAL APHERESIS. DOI: 10.1002/JCA.21743.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN THE JOURNAL OF CLINICAL APHERESIS TITLED " PERFORMANCE CHARACTERISTICS OF THE POWERFLOW APHERESIS PORT: EARLY EXPERIENCE " THAT IN A PROSPECTIVE STUDY OF FOUR PATIENTS UNDERGOING OUTPATIENT THERAPEUTIC PLASMA EXCHANGE (TPE), PRESSURE ALARM OCCURRED IN SIX OF THE FORTY SEVEN PROCEDURES. IT WAS FURTHER REPORTED THAT THE HEALTHCARE PROVIDERS ATTEMPTED TO USE VERY FAST INLET FLOW RATE, HOWEVER, IT WAS RESOLVED BY LOWERING THE INLET FLOW RATE BY 10% IN FIVE OF THEM. IN PATIENT NUMBER TWO, THE PRESSURE ALARM OCCURRED DUE TO THROMBUS, HOWEVER, IT WAS RESOLVED BY PAUSING THE PROCEDURE, ASPIRATING AND THEN FLUSHING THE PORT WITH SALINE. THE CURRENT STATUS OF THE PATIENTS WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960422 POWERFLOW 16G IV PORT INTER APHERESIS PORT PTD BARD ACCESS SYSTEMS A710962 UNKNOWN 00801741129438

    Patients

    Seq Age Sex Outcome Treatment
    1