BEUDAMED
    FDA Adverse Event Other Summary report: N

    CUSTOM TRANSDUCER MONITORING KIT

    MDR report key: 2923256 · Received January 10, 2013

    Report

    Report Number
    2025816-2012-00040
    Event Type
    Other
    Date Received
    January 10, 2013
    Date of Event
    March 6, 2012
    Report Date
    March 30, 2012
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG. LOT DATABASE FOR THE REPORTED LOT# 2092903 (MFG. DATE 11/2010) SHOWS (B)(4) UNITS WERE MFG., TESTED, INSPECTED, AND RELEASED. CONCLUSION: THE REPORTED PRODUCT PROBLEM WAS CONFIRMED. THE EXACT CAUSE REMAINS UNK. THIS REPORT AND THE ASSOCIATED INFO HAVE BEEN ENTERED IN OUR DATABASE FOR ANALYSIS AND TRENDING.

    Description of Event or Problem · 1

    INT'L ((B)(6)) COMPLAINT REC'D REPORTING NO READINGS/SIGNAL DURING ATTEMPTED USE OF ONE (1) 0111-0J736-01 TRANSDUCER MTO KIT. IT WAS REPORTED "..ONE PT HAD HEART FAILURE WITH SHOCK AT BLOCK. WHEN INSTALLING THE ARTERIAL LINE WITH THE 011-0736-01, THERE WAS NO SIGNAL TO THE MONITOR... BELIEVED THAT IT WAS A MONITOR PROBLEM OR TP-CABLE PROBLEM. THEY HAD NO SPARE KIT. ...THEY HAD TO ADMINISTER DRUGS WITH REFERENCE ONLY TO THE PT'S HEARTBEAT AND DOING AN INJECTION IN REFERENCE TO THE HEART BEAT. THE PT STABILIZED AND WAS TRANSFERRED TO INTENSIVE CARE UNIT. THERE THEY INSTALLED ANOTHER 011-0J736-01 FROM THE SAME BATCH THAT WORKED PERFECTLY ... THINKS THERE HAS BEEN A PROBLEM FOR ELECTRICAL CONNECTION AT THE TRANSPAC IT". THE 011-0J736-01 WAS PRE-TESTED DURING SET-UPS WITH NO PROBLEMS DETECTED AT THAT TIME. MFR'S ANALYSIS AND INVESTIGATION: DEVICE RETURN: ONE (1) "PARTIAL" 011-0J736-01 MONITORING KIT (TRANSPAC IT, STOPCOCK, AND 2 TUBING SUBASSY) WERE RETURNED FOR ANALYSIS. VISUAL INSPECTION RECORDED NO OBVIOUS ABNORMALITIES. ENGINEERING ELECTRICAL TESTING AND ANALYSIS RECORDED THE RETURNED PARTIAL MONITORING KIT TRANSPAC COMPONENTS FAILED TO PRODUCE THE WAVE FORM READINGS. THE ROOT CAUSE OF THE ELECTRICAL FAILURE WAS ATTRIBUTABLE TO THE TRANSPAC INTEGRATED TRANSDUCER COMPONENT. AS THIS IS A PURCHASED COMPONENT, A SUPPLIER CORRECTIVE ACTION REPORT WAS GENERATED AND THE COMPONENT/UNIT RETURNED TO THE SUPPLIER FOR ANALYSIS. THE SUPPLIERS INVESTIGATION DID CONFIRM A CABLE FAILURE BUT AS OF THIS DATE HAVE NOT BEEN ABLE TO IDENTIFY ROOT CAUSE. HEIGHTENED INSPECTIONS HAVE BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13997 CUSTOM TRANSDUCER MONITORING KIT CUSTOM MONITORING KIT DQO ICU MEDICAL, INC. 011-0J736-01 2092903

    Patients

    Seq Age Sex Outcome Treatment
    1 MONITOR MFR: MAKE MODEL UNK