BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS POSITIVE PRESSURE CONNECTOR

    MDR report key: 11004428 · Received December 14, 2020

    Report

    Report Number
    9616066-2020-20568
    Event Type
    Malfunction
    Date Received
    December 14, 2020
    Date of Event
    October 20, 2020
    Report Date
    December 15, 2020
    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 · 0

    H.6. INVESTIGATION: A MP1000 CHINA PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT 20055178. NO FURTHER INFORMATION WAS AVAILABLE TO ASSIST THE INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 20055178 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MAXPLUS POSITIVE PRESSURE CONNECTOR LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "ON 2020.10.20, THE NEEDLELESS INFUSION CONNECTOR WAS USED FOR THE PATIENT'S INFUSION. THE NEEDLELESS CONNECTOR WAS FOUND TO BE LEAKING DURING USE, AND IT COULD NOT BE USED."

    Additional Manufacturer Narrative · 1

    LOT: MP1000 CHINA 510K: THIS IS AN INTERNATIONAL CODE- THE MODEL#/CATALOG# IDENTIFIED 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 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MAXPLUS POSITIVE PRESSURE CONNECTOR LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "ON (B)(6) 2020, THE NEEDLELESS INFUSION CONNECTOR WAS USED FOR THE PATIENT'S INFUSION. THE NEEDLELESS CONNECTOR WAS FOUND TO BE LEAKING DURING USE, AND IT COULD NOT BE USED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1466824 MAXPLUS POSITIVE PRESSURE CONNECTOR INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 20055178

    Patients

    Seq Age Sex Outcome Treatment
    1