BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS POSITIVE PRESSURE CONNECTOR

    MDR report key: 10073284 · Received May 19, 2020

    Report

    Report Number
    9616066-2020-01541
    Event Type
    Malfunction
    Date Received
    May 19, 2020
    Date of Event
    April 29, 2020
    Report Date
    April 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    A MP1000 CHINA PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER THE CUSTOMER INDICATES THAT LEAKAGE WAS IDENTIFIED AT THE CONNECTION TO A PICC LINE. FURTHER INFORMATION PROVIDED BY THE CUSTOMER INDICATES THAT NO OBVIOUS DAMAGE WAS VISIBLE WHICH MAY HAVE CONTRIBUTED TO THE CUSTOMER'S EXPERIENCE. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 16018067 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 · 0

    IT WAS REPORTED THAT THE MAXPLUS POSITIVE PRESSURE CONNECTOR EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONNECTOR WAS LEAKAGE, AND THE LIQUID WAS LEAKAGE FROM SCREW JOINT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: A MP1000 PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER THE CUSTOMER INDICATES THAT A LEAKAGE WAS IDENTIFIED AT THE CONNECTION TO THE MALE LUER COMPONENT. FURTHER INFORMATION RELATING TO THE INFUSION SET UP CONFIRMED THE CONNECTING PRODUCTS WERE BARD PICC CATHETER AND A KDL LUER SLIP SYRINGE. ROOT CAUSE DESCRIPTION: DHR FOR THIS COMPLAINT: (B)(4), LOT 16018067, MODEL MP1000 CHINA, (B)(4), MFG DATE 1/17/2016. NO QN¿S OR DEVIATIONS DURING THE LOT MANUFACTURING. INVESTIGATION CONCLUSION: THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 16018067 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 THERE ARE A SMALL NUMBER OF SIMILAR REPORTS; HOWEVER, THESE COMPLAINTS HAVE NOT BEEN ATTRIBUTABLE TO A MAXPLUS PRODUCT DEFECT. 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 EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONNECTOR WAS LEAKAGE, AND THE LIQUID WAS LEAKAGE FROM SCREW JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537171 MAXPLUS POSITIVE PRESSURE CONNECTOR INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C. 16018067

    Patients

    Seq Age Sex Outcome Treatment
    1 Other