BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOGICAL KIT

    MDR report key: 1021564 · Received March 27, 2008

    Report

    Report Number
    1526863-2008-00010
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Report Date
    February 26, 2008
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    DRS
    PMA / PMN Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBASSEMBLY IN QUESTION IS A560 AND IS MFG BY SMITHS MEDICAL ASD. THIS ASSEMBLY IS INCORPORATED INTO THE FINISHED PRODUCT BY SMITHS MEDICAL INTL. THE FINISHED PRODUCT IS FURTHER ASSEMBLED, PACKAGED AND STERILIZED BY SMITHS MEDICAL INTL. ONE A560 SUBASSEMBLY WAS RECEIVED WITH THE TUBING SEPARATED FROM THE FEMALE LUER LOCK. THE SOLVENT RING ON THE TUBING FROM BOTH COMPONENTS SHOWED THE TUBING HAD BEEN FULLY SEATED INTO THEIR CORRESPONDING CONNECTORS AND SOLVENT APPLIED. THE TUBING MEASURED WITHIN SPECS. THERE DID NOT APPEAR TO BE ANY MFG ISSUES. THE TUBING ASSEMBLY IN QUESTION WAS MFG ON AN AUTOMATIC TUBING ASSEMBLY MACHINE. THE PRODUCT IS 100% VISUALLY INSPECTED BY THE OPERATOR FOR PROPER ASSEMBLY AND SUFFICIENT SOLVENT. AS A PRECAUTION IN JULY 2007 THE ASSEMBLY ROUTING INSTRUCTIONS FOR THE ASSEMBLY MACHINE WERE MODIFIED TO REQUIRE OPERATOR SIGN OFF FOR THE SOLVENT PURGING ON THE MACHINE ALONG WITH DOCUMENTING THE 100% INSPECTION. AS PART OF THE INSPECTION PROCESS, ANY UNITS REMOVED DURING THE 100% WERE REMOVED BY THE OPERATOR. ALSO AS A PRECAUTION IN MID DECEMBER 2007, THIS PRACTICE HAS BEEN DISCONTINUED. ANY UNITS REMOVED DURING THE 100% INSPECTION ARE BEING DISCARDED. SMITHS WAS ABLE TO CONFIRM THE ISSUE; HOWEVER, NO ROOT CAUSE COULD BE DETERMINED. NO ADDITIONAL ACTION IS NECESSARY AT THIS TIME. SMITHS CONSIDERS THIS MDR CLOSED WITH THIS REPORT.

    Description of Event or Problem · 1

    REPORTER REPORTED TO SMI THAT THE CONNECTION AT THE MLL TO THE ARTERIAL LINE WAS LEAKING AND/OR DETACHED FROM THE TUBING. THIS WAS OBSERVED DURING USE IN THE ICU. THERE WAS NO PT INJURY OR TREATMENT REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOGICAL KIT PRESSURE MONITORING SET DRS SMITHS MEDICAL ASD, INC. NA 1200088

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK