BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS POSITIVE PRESSURE CONNECTOR

    MDR report key: 12132323 · Received July 7, 2021

    Report

    Report Number
    9616066-2021-51467
    Event Type
    Malfunction
    Date Received
    July 7, 2021
    Date of Event
    June 7, 2021
    Report Date
    June 22, 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 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. INVESTIGATION SUMMARY: AN MP1000 CHINA PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT 20076476. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER CONFIRMED THE OCCLUSION WAS IDENTIFIED WHILST CONNECTED TO A RONGDE LUER SLIP SYRINGE DURING THE PROCESS OF AN AIR EXHAUST. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 20076476 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. IT WAS NOT POSSIBLE TO CONFIRM THE ROOT CAUSE OF THE REPORTED ISSUE IN THIS INSTANCE, WITHOUT A SAMPLE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED OCCLUSION. 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 2 MAXPLUS POSITIVE PRESSURE CONNECTORS WERE BLOCKED DURING NEUROSURGERY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "NEUROSURGERY, NEEDLE FREE CONNECTOR TUBING WERE BLOCKED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023905 MAXPLUS POSITIVE PRESSURE CONNECTOR INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 20076476

    Patients

    Seq Age Sex Outcome Treatment
    1