BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS POSITIVE PRESSURE CONNECTOR

    MDR report key: 12254845 · Received July 30, 2021

    Report

    Report Number
    9616066-2021-51660
    Event Type
    Malfunction
    Date Received
    July 30, 2021
    Date of Event
    June 18, 2021
    Report Date
    July 16, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K072542
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 SECTION G5 IS FOR THE DOMESTIC SIMILAR PRODUCT: K072542. INVESTIGATION SUMMARY: A MP1000 CHINA PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT 20085930. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 20085930 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 AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. IN THIS INSTANCE, WITHOUT A SAMPLE, IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT COMPLAINTS OF THIS NATURE ARE RARE AND THERE IS CURRENTLY NO TREND FOR ISSUES OF THIS NATURE AGAINST THE MP1000 CHINA PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MAXPLUS POSITIVE PRESSURE CONNECTOR HAD FLOW ISSUES AND WAS BLOCKED DURING THE INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THE LIQUID DOES NOT DRIP AFTER THE INFUSION SET IS CONNECTED. THE LIQUID DROPS SUCCESSFULLY AFTER THE REPLACEMENT OF THE POSITIVE PRESSURE CONNECTOR. "THE JOINT IS BD'S MP1000 NEEDLE FREE JOINT, AND THERE IS NO PROBLEM WITH THE JOINT. WHEN THE PRECHARGE IS PUSHED TO 3/1--2/1, IT CANNOT BE PUSHED COMPLETELY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1148236 MAXPLUS POSITIVE PRESSURE CONNECTOR INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 20085930

    Patients

    Seq Age Sex Outcome Treatment
    1