BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXZERO NEEDLELESS CONNECTOR

    MDR report key: 7827656 · Received August 29, 2018

    Report

    Report Number
    9616066-2018-01479
    Event Type
    Malfunction
    Date Received
    August 29, 2018
    Date of Event
    July 7, 2018
    Report Date
    August 5, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403230196
    PMA / PMN Number
    K132413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    TOTAL CONCOMITANT PRODUCTS FOR THIS EVENT ARE: 2432-0007, (3) MZ 1000-07, (1) MZ 9226, MZ5306, (2) 20ML SYRINGE, 60ML SYRINGE, (2) NON BD EXTENSION SETS, NON-BD SET, 500ML BAXTER BAG REF (B)(4) LOT 60106901 EXP 2020-12 EXACTA MIX; 20ML SYRINGE REF (B)(4) LOT 10010843 EXP 08/19/2018 0.9% SODIUM CHLORIDE, QUEST MEDICAL MODEL 95702, SMITHS MEDICAL MODEL 448HL60, THE CUSTOMER REPORT OF LEAKING EVENTS WAS CONFIRMED. THE PATIENT WAS AN INFANT. VISUAL INSPECTION OF THE SET NOTED NO DISCERNIBLE SIGNS OF DAMAGE OR ABNORMALITIES. EXAMINATION UNDER MAGNIFICATION OBSERVED A MICROCHANNEL/SCRATCH WITHIN THEIR INTERIOR DIAMETER AND A SECOND OBSERVATION WAS FROM A VALVE COMPONENT ATTACHED BETWEEN A NON-BD EXTENSION SET AND NON-BD BIFUSE EXTENSION SET IN WHICH A CRACK WAS OBSERVED RUNNING ALONG ONE SIDE OF THE TOP OF THE VALVE COMPONENT AND CONTINUING ALONG THE THREADS OF THE VALVE. FUNCTIONAL AND PRESSURE TESTING CONFIRMED LEAKING FROM THE TOPS OF THREE MAXZERO VALVE COMPONENTS. THE ROOT CAUSE OF THE OBSERVED LEAKS WERE IDENTIFIED AS THE FOLLOWING- MICROCHANNEL/SCRATCH WITHIN THE INTERIOR DIAMETER OF MAXZERO VALVE COMPONENTS IN WHICH THE ROOT CAUSE OF THE MICROCHANNEL, WHICH CREATES A FLUID PATH, IS DUE TO AN EQUIPMENT ERROR DURING THE INSPECTION AND TESTING PROCESS DURING FINAL ASSEMBLY OF THE MAXZERO COMPONENT; AND A CRACK ON THE TOP OF A MAXZERO VALVE COMPONENT IN WHICH THE ROOT CAUSE OF THE DAMAGE WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED 3 LEAKING EVENTS THAT OCCURRED ON THE SAME PATIENT IN NICU IV DEPARTMENT: FIRST, THE TUBING LEAKED TPN AT THE MAXZERO¿ CONNECTION IN WHICH THE MAXZERO¿ WAS CHANGED WITHOUT FURTHER COMPLICATIONS. SECOND, THE CUSTOMER REPORTED THAT THE OLD INTRALIPID TUBING WAS USED, AND THE END PORT WAS CRACKED AND LEAKING. TUBING WAS CHANGED TO A NEW INTRALIPID TUBING SET AND THERE WAS NO FURTHER LEAKING NOTED. THIRD, THE TUBING LEAKED PGE AT THE MAXZERO¿ SITE IN WHICH THE MAXZERO¿ WAS CHANGED WITHOUT FURTHER COMPLICATIONS. THE MANIFOLD HAD TO BE REMOVED DUE TO LEAKING. THERE WAS NO REPORT OF PATIENT HARM.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: (2)PRI TUBING. ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 500ML BAXTER BAG REF H938738 LOT 60106901 EXP 2020-12 EXACTA MIX; 20ML SYRINGE REF 70092121747 LOT 10010843 EXP 08/19/2018 0.9% NACL, NON BD SET; MZ1000-07; (2) NON BD EXTENSION SETS. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LEAKING TPN AT THE MAXZERO. THE CUSTOMER ALSO REPORT THE OLD INTRALIPID TUBING WAS USED, AND THE END PORT WAS CRACKED AND LEAKING. TUBING WAS CHANGED TO NEW INTRALIPID TUBING AND THERE WAS NO MORE LEAKING. THIRDLY, THERE WAS A LEAK ON THE PGE LINE AT THE MAXZERO SITE. THE MANIFOLD HAD TO BE REMOVED DUE TO LEAKING. THERE WAS NO REPORT OF PATIENT HARM. THE CUSTOMER LATER REPORTED THE INTRALIPID TUBING IS A NON-BD PRODUCT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED 3 LEAKING EVENTS THAT OCCURRED ON THE SAME PATIENT: FIRST, THE TUBING LEAKED TPN AT THE MAXZERO¿ CONNECTION IN WHICH THE MAXZERO¿ WAS CHANGED WITHOUT FURTHER COMPLICATIONS. SECOND, THE CUSTOMER REPORTED THAT THE OLD INTRALIPID TUBING WAS USED, AND THE END PORT WAS CRACKED AND LEAKING. TUBING WAS CHANGED TO A NEW INTRALIPID TUBING SET AND THERE WAS NO FURTHER LEAKING NOTED. THIRD, THE TUBING LEAKED PGE AT THE MAXZERO¿ SITE IN WHICH THE MAXZERO¿ WAS CHANGED WITHOUT FURTHER COMPLICATIONS. THE MANIFOLD HAD TO BE REMOVED DUE TO LEAKING. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671119 MAXZERO NEEDLELESS CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION MZ1000-07 10885403230196

    Patients

    Seq Age Sex Outcome Treatment
    1 (2)8100,(2)8015,95702,448HL60, TD (B)(6) 2018| 8015, 8100, 8110| 8100,8015,8110,(2)MY8020,MY8060,MZ9226,MZ5307