BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 2850169 · Received October 8, 2012

    Report

    Report Number
    2021710-2012-00089
    Event Type
    Malfunction
    Date Received
    October 8, 2012
    Date of Event
    August 23, 2012
    Report Date
    August 23, 2012
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT PROVIDE ANY PATIENT OR DEVICE CODES ON THEIR USER FACILITY REPORT. CODES WERE DERIVED BASED ON THE INFORMATION PROVIDED BY THE USER FACILITY OF THE USER FACILITY MEDWATCH REPORT RECEIVED FROM THE (B)(6) 2012 AND INFORMATION DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE ON (B)(6) 2012. THIS IS A KNOWN ISSUE THAT IS ALREADY BEING ADDRESSED, THUS NO ADDITIONAL INVESTIGATION/EVALUATION IS REQUIRED. CAREFUSION HAS INITIATED A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) TO THE SUPPLIER OF THE CAP/DIAPHRAGM ASSEMBLY AS A PART OF OUR CORRECTIVE AND PREVENTATIVE ACTION SYSTEM TO ADDRESS THIS ISSUE. CAREFUSION HAS CONDUCTED A RISK ASSESSMENT RELATED TO THIS ISSUE AND HAS DETERMINED THE RISK TO BE AS LOW AS REASONABLY PRACTICABLE (ALARP).

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED ON (B)(6) 2012, BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE. "[(B)(6)] CALLED VERY UPSET ABOUT THE CAP/DIAPHRAGM ISSUE. HE HAD ISSUES FEW MONTHS AGO AND THE REPLACEMENTS WE SENT WERE ALSO BAD AND STAFF HAS THROWN AWAY CIRCUITS TO TROUBLESHOOT. ADVISED WILL REPLACE CAPS AND CIRCUITS. SIX TO EIGHT SETS OF CAPS WERE USED AND 3 CIRCUITS WERE THROWN AWAY. ADVISED WOULD SEND 2 MORE BOXES OF CAPS AND A REPLACEMENT BOX OF CIRCUITS." THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM THE USER FACILITY MEDWATCH REPORT RECEIVED BY CAREFUSION FROM (B)(6) 2012. "A RESPIRATORY THERAPIST HAD DIFFICULTY IN COMPLETING AN OPERATIONAL VERIFICATION OF AN OSCILLATOR VENT PRIOR TO USE. THE VENT WOULD NOT PRESSURIZE FULLY DURING A CALIBRATION SET UP. EVENTUALLY THE FAULT WAS DETERMINED TO BE IN THE WHITE "DIAPHRAGM CAPS" ATTACHED TO THE BREATHING CIRCUIT. REPLACEMENT CAPS WERE OBTAINED FROM STOCK, WHICH ALSO FAILED. ONLY WHEN CAPS WERE TAKEN FROM ANOTHER VENT ALREADY PREPARED FOR USE WAS THE CALIBRATION SUCCESSFUL. THE MANUFACTURER WAS CONTACTED, AND THEY ADMITTED THAT PROBLEMS HAD BEEN FOUND WITH THE BLUE INNER DIAPHRAGMS OF SOME CAPS, ALTHOUGH SPECIFIC LOT NUMBERS WERE NOT IDENTIFIED. WE HAD NO RECEIVED NO NOTICE OF THAT PROBLEM UNTIL WE CALLED. OUR LOT NUMBER HAS BEEN PULLED FROM STOCK, AND MFR IS SENDING REPLACEMENTS. A SIMILAR PROBLEM OCCURRED PREVIOUSLY IN (B)(6) OF 2012. AT THAT TIME, THE MANUFACTURER ADMITTED SPORADIC PROBLEMS WITH THE CAPS, BUT COULD NOT IDENTIFY ANY SPECIFIC LOT NUMBERS. WE THINK THERE SHOULD HAVE BEEN NOTIFICATION TO USERS OF POTENTIAL PROBLEMS WITH THESE CAPS. WE SHOULD NOT HAVE HAD TO LEARN OF THE PROBLEM BY CALLING THE MANUFACTURER ABOUT OUR EXPERIENCE. THE MANUFACTURER HAS CONFIRMED A PROBLEM IN MOLDING OR OTHER PROCESSES INVOLVING THE BLUE INNER DIAPHRAGM OF SOME OF THESE CAPS, BUT SPECIFIC LOT NUMBERS WERE NOT IDENTIFIED. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? SETUP OF OSCILLATOR VENT FOR USE ON CRITICAL CARE PATIENT. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION- THAT IS, THE DEVICE DID NOT DO WHAT IS WAS SUPPOSED TO DO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORMEDICS VENTILATOR, HIGH FREQUENCY / LSZ LSZ CAREFUSION CAP.DIAPHRAGM SET 0000437628

    Patients

    Seq Age Sex Outcome Treatment
    1 NA