BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXPLUS POSITIVE PRESSURE CONNECTOR

    MDR report key: 10051771 · Received May 13, 2020

    Report

    Report Number
    9616066-2020-01407
    Event Type
    Injury
    Date Received
    May 13, 2020
    Date of Event
    January 8, 2019
    Report Date
    April 17, 2020
    Manufacturer
    CFN MEXICO 215 SA DE CV
    Product Code
    FPA
    PMA / PMN Number
    K072542
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A MP1000 CHINA SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION OF THIS FEEDBACK; HOWEVER THE CUSTOMER INDICATES THAT A LEAKAGE WAS IDENTIFIED FROM THE CONNECTION OF THE MAXPLUS TO A PICC LINE. FURTHER INFORMATION RELATING TO THE CUSTOMER'S EXPERIENCE WAS NOT 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 16018065 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 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. 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 MAXPLUS PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MAXPLUS POSITIVE PRESSURE CONNECTOR LEAKED "ABOUT 20 ML" OF FLUID FROM THE "FROM PICC OXALIPLATIN INTO POSITIVE PRESSURE JOINT WITH EXTENSION TUBE JOINT DRAINAGE" INTO THE PATIENT'S BED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PATIENT WAS GIVEN PICC TUBE WITH OXALIPLATIN CHEMOTHERAPY ON 1.8. AFTER THE DRUG WAS GIVEN BY GIO MICROPUMP BEFORE CHEMOTHERAPY , THE PATIENT WAS GIVEN OXALIPLATIN AFTER THE INFUSION SET WAS CONNECTED TO THE EXTENDED TUBE AND FLUSHING THE TUBE AT 14:19 ON 1.8 . AT THAT TIME, THE VENOUS ACCESS WAS UNOBSTRUCTED AND THERE WAS NO LEAKED FLUID. AT 14:50 THE PATIENT WAS RINGING THE BELL BECAUSE PATIENT FELT WET WITH CLOTHES, NURSE WENT TO SEE THE PATIENT, AND SHE FOUND THAT SLEEVES AND BED SHEETS WERE GOT WET, THE LEAKED LIQUID WAS ABOUT 20 ML, CONSIDERED THAT LEAKAGE WAS FROM PICC OXALIPLATIN INTO POSITIVE PRESSURE JOINT WITH EXTENSION TUBE JOINT DRAINAGE, SO THE NURSE IMMEDIATELY STOPPED THE INFUSION, AND CONTINUED TO INFUSION AFTER REMOVING EXTENSION TUBE, THEN THE NURSE CHANGED THE SHEETS AND CLOTHES, THE PATIENT PRESENTED WITH NO DISCOMFORT. THE NURSE REPORTED TO THE COMPETENT DOCTOR, AND TOLD THE PATIENT TO WAIT FOR FURTHER OBSERVATION."

    Additional Manufacturer Narrative · 1

    MP1000 (B)(6) 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MAXPLUS POSITIVE PRESSURE CONNECTOR LEAKED "ABOUT 20 ML" OF FLUID FROM THE "FROM PICC OXALIPLATIN INTO POSITIVE PRESSURE JOINT WITH EXTENSION TUBE JOINT DRAINAGE" INTO THE PATIENT'S BED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PATIENT WAS GIVEN PICC TUBE WITH OXALIPLATIN CHEMOTHERAPY ON 1.8. AFTER THE DRUG WAS GIVEN BY GIO MICROPUMP BEFORE CHEMOTHERAPY , THE PATIENT WAS GIVEN OXALIPLATIN AFTER THE INFUSION SET WAS CONNECTED TO THE EXTENDED TUBE AND FLUSHING THE TUBE AT 14:19 ON 1.8 . AT THAT TIME, THE VENOUS ACCESS WAS UNOBSTRUCTED AND THERE WAS NO LEAKED FLUID. AT 14:50 THE PATIENT WAS RINGING THE BELL BECAUSE PATIENT FELT WET WITH CLOTHES, NURSE WENT TO SEE THE PATIENT, AND SHE FOUND THAT SLEEVES AND BED SHEETS WERE GOT WET, THE LEAKED LIQUID WAS ABOUT 20 ML, CONSIDERED THAT LEAKAGE WAS FROM PICC OXALIPLATIN INTO POSITIVE PRESSURE JOINT WITH EXTENSION TUBE JOINT DRAINAGE, SO THE NURSE IMMEDIATELY STOPPED THE INFUSION, AND CONTINUED TO INFUSION AFTER REMOVING EXTENSION TUBE, THEN THE NURSE CHANGED THE SHEETS AND CLOTHES, THE PATIENT PRESENTED WITH NO DISCOMFORT. THE NURSE REPORTED TO THE COMPETENT DOCTOR, AND TOLD THE PATIENT TO WAIT FOR FURTHER OBSERVATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514905 MAXPLUS POSITIVE PRESSURE CONNECTOR INTRAVASCULAR ADMINISTRATION SET FPA CFN MEXICO 215 SA DE CV MP1000 CHINA 16018065

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention