BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL VLV ADPT(STAND ALONE)

    MDR report key: 10145968 · Received June 11, 2020

    Report

    Report Number
    9616066-2020-01751
    Event Type
    Malfunction
    Date Received
    June 11, 2020
    Date of Event
    May 20, 2020
    Report Date
    May 20, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.
    Product Code
    FPA
    UDI-DI
    07613203011938
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. LOT # 2003669 INVESTIGATION CONCLUSION A 2000E PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT 20036691. FURTHER INFORMATION 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 20036691 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, HOWEVER PREVIOUS COMPLAINTS FOR OCCLUSIONS OF THE SMARTSITE HAVE BEEN RELATED TO FEATURES ON THE SURFACE OF THE MALE LUER OF THE CONNECTING PRODUCTS. THESE FEATURES INCLUDE FLASH OR A RAISED EDGE TO THE TIP OF THE MALE LUER WHICH HAVE PREVIOUSLY BEEN SHOWN TO INTERMITTENTLY LEAD TO RESTRICTED FLOW DUE TO THEM PINCHING THE BLUE PISTON OF THE SMARTSITE AND NOT ALLOWING IT TO OPEN. THIS CAN SOMETIMES BE RESOLVED BY DISCONNECTING AND REATTACHING THE SAME LUER CONNECTION WHICH MAY REPOSITION THE LUER AGAINST THE PISTON AND IMPROVE THE FLOW, OR ALTERNATIVELY BY CHANGING THE CONNECTING MALE LUER. IN THIS INSTANCE THE CONNECTING PRODUCT IN USE AT THE TIME OF THE CUSTOMER'S EXPERIENCE WAS NOT AVAILABLE FOR INVESTIGATION AND THEREFORE IT HAS NOT BEEN POSSIBLE TO CONFIRM IF THIS MAY HAVE 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 SMARTSITE PRODUCT DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 LL VLV ADPT(STAND ALONE) WERE CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SMARTSSITE CONNECTOR UNABLE TO BE FLUSHED OR ASPIRATED BY ITSELF OR CONNECTED TO PATIENT CANNULA. CHANGED AND TESTED ANOTHER 2X CONNECTORS FROM THE SAME BATCH WITH SAME ISSUE. PRODUCT DISCARDED.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: CUSTOMER PROVIDED AN INVALID LOT # AS 20036691. DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 LL VLV ADPT(STAND ALONE) WERE CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SMARTSITE CONNECTOR UNABLE TO BE FLUSHED OR ASPIRATED BY ITSELF OR CONNECTED TO PATIENT CANNULA. CHANGED AND TESTED ANOTHER 2X CONNECTORS FROM THE SAME BATCH WITH SAME ISSUE. PRODUCT DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605538 LL VLV ADPT(STAND ALONE) INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C. 20036691 07613203011938

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 20200520| 20200520