BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS POSITIVE PRESSURE CONNECTOR

    MDR report key: 10049504 · Received May 12, 2020

    Report

    Report Number
    2016493-2020-00577
    Event Type
    Malfunction
    Date Received
    May 12, 2020
    Date of Event
    July 28, 2019
    Report Date
    April 17, 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 SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION OF THIS FEEDBACK; HOWEVER THE CUSTOMER INDICATES THAT AN OCCLUSION WAS IDENTIFIED WHEN ATTEMPTING TO ACCESS THE MAXPLUS DEVICE. NO FURTHER INFORMATION REGARDING THE EVENT WAS AVAILABLE TO ASSIST THE INVESTIGATION. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 15128104 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 ISSUE. IN THIS INSTANCE THE CONNECTING PRODUCT IN USE AT THE TIME OF THE CUSTOMER'S EXPERIENCE WAS NOT AVAILABLE FOR INVESTIGATION AND THEREFORE IT COULD NOT BE DETERMINED IF IT MAY HAVE 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 PRODUCT. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MAXPLUS POSITIVE PRESSURE CONNECTOR WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS ADMITTED DUE TO "SHORTNESS OF BREATH ACCOMPANIED BY BILATERAL LOWER LIMB EDEMA FOR HALF A MONTH". ON (B)(6) 2019, THE INFUSION OBSTRUCTION HAPPENED IN THE INFUSION PROCESS ON THIS PATIENT, AND THE PRESSURE WAS NORMAL WHEN USING SALINE TO FLUSH THE TUBE . AFTER THAT, THE DISPOSABLE INFUSION JOINT WAS UNSCREWED WITH THE NEEDLE-FREE CONNECTOR, PART OF THE INFUSION WAS SMOOTH, AND THERE WAS NO HARM TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. MP1000 CHINA 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MAXPLUS POSITIVE PRESSURE CONNECTOR WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS ADMITTED DUE TO "SHORTNESS OF BREATH ACCOMPANIED BY BILATERAL LOWER LIMB EDEMA FOR HALF A MONTH". ON (B)(6) 2019, THE INFUSION OBSTRUCTION HAPPENED IN THE INFUSION PROCESS ON THIS PATIENT, AND THE PRESSURE WAS NORMAL WHEN USING SALINE TO FLUSH THE TUBE. AFTER THAT, THE DISPOSABLE INFUSION JOINT WAS UNSCREWED WITH THE NEEDLE-FREE CONNECTOR, PART OF THE INFUSION WAS SMOOTH, AND THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511668 MAXPLUS POSITIVE PRESSURE CONNECTOR INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C. 15128104

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 20190728