BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS POSITIVE PRESSURE CONNECTOR

    MDR report key: 10428670 · Received August 19, 2020

    Report

    Report Number
    9616066-2020-02530
    Event Type
    Malfunction
    Date Received
    August 19, 2020
    Date of Event
    June 1, 2020
    Report Date
    July 29, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.
    Product Code
    FPA
    PMA / PMN Number
    K072542
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A MP1000 CHINA SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION OF THIS FEEDBACK; HOWEVER THE CUSTOMER INDICATES THAT A LEAKAGE WAS IDENTIFIED DURING INFUSION. FURTHER INFORMATION PROVIDED BY THE CUSTOMER INDICATED THE LEAKAGE WAS IDENTIFIED WHEN THE SAMPLE WAS CONNECTED TO HONGDA PICC AND INFUSION SETS; FURTHERMORE THE LEAKAGE WAS OBSERVED THREE HOURS INTO THE INFUSION. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 16028086 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED IN THIS INSTANCE. WITHOUT A SAMPLE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. PLEASE NOTE THE CUSTOMER CONFIRMED THE LEAKAGE WAS IDENTIFIED AT LEAST 3 HOURS AFTER COMMENCING THE INFUSION SO IT IS UNLIKELY THAT A MANUFACTURING DEFECT COULD HAVE CONTRIBUTED TO THE CUSTOMER'S EXPERIENCE IN THIS INSTANCE. IN THIS INSTANCE, WITHOUT THE COMPLAINT SAMPLE OR ADDITIONAL INFORMATION ABOUT THE EXACT NATURE OF THE DEFECT IT IS NOT POSSIBLE TO CONCLUSIVELY LINK THIS FEEDBACK TO A SPECIFIC FAILURE MODE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MAXPLUS POSITIVE PRESSURE CONNECTOR EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS OPERATED IN OUR HOSPITAL DUE TO GASTRIC CANCER. BEFORE THE OPERATION, PICC WAS PLACED FOR INFUSION THERAPY. AFTER THE CONNECTOR WAS CHANGED, THE INFUSION CONNECTOR LEAKED DURING INFUSION.

    Additional Manufacturer Narrative · 1

    MP1000 CHINA 510K THIS IS AN INTERNATIONAL CODE- THE MODEL#/CATALOG# IDENTIFIED IN IS A CAREFUSION PRODUCT WHICH IS SAME OR SIMILAR TO A DEVICE THAT IS APPROVED FOR SALE DOMESTICALLY. THE DOMESTIC SIMILAR LIST NUMBER IS MP1000. THE 510K NUMBER PROVIDED IN IS FOR THE DOMESTIC SIMILAR PRODUCT.-K072542. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MAXPLUS POSITIVE PRESSURE CONNECTOR EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS OPERATED IN OUR HOSPITAL DUE TO GASTRIC CANCER. BEFORE THE OPERATION, PICC WAS PLACED FOR INFUSION THERAPY. AFTER THE CONNECTOR WAS CHANGED, THE INFUSION CONNECTOR LEAKED DURING INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888863 MAXPLUS POSITIVE PRESSURE CONNECTOR INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C. 16028086

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 20200601| 20200601