BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASSY PAT CIRC PEEPLESS ADULT SPU

    MDR report key: 5335169 · Received December 30, 2015

    Report

    Report Number
    2050001-2015-00027
    Event Type
    Injury
    Date Received
    December 30, 2015
    Date of Event
    December 4, 2015
    Report Date
    December 20, 2016
    Manufacturer
    CAREFUSION
    Product Code
    CAI
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER ON DECEMBER 21, 2015 STATING THE FOLLOWING: ¿CUSTOMER STATED "HOSPITAL BED WITH PATIENT ON BOARD WAS LINED UP TO AIRCRAFT FOR LOADING OF PATIENT. THE REVEL VENT WAS BEING HELD BY HOSPITAL PERSONNEL AT HEAD OF PATIENT. PRIOR TO LOADING OF PATIENT IN AIRCRAFT, THE BROKEN TUBING IN QUESTION WAS FOUND. PATIENT WAS REMOVED FROM THE REVEL VENT AND VENTILATION WAS CONTINUED UTILIZING A SELF-INFLATING BAG W/PEEP VALVE. AN AUDIBLE VENT ALARM WAS NOT HEARD NOR SILENCED. UNAWARE IF ANY EXCESSIVE FORCE OR TUGGING OCCURED ON THE CIRCUIT. COMPLEX PATIENT WITH MULTIPLE LINES, TUBES, ETC. REQUIRING NUMEROUS PERSONNEL TO MOVE PATIENT FROM ICU TO HELIPAD. CRITICALLY ILL PATIENT WHO REQUIRED A HIGH FI02 (1.0), RESPIRATORY RATE (30), AND PEEP (18 CMH20) TO MEET OXYGENATION/VENTILATION REQUIREMENTS. CONCERN IS THAT A BREAK IN THE TUBING IN QUESTION RESULTED IN LOSS OF ALVEOLAR RECRUITMENT AND CLINICAL DETERIORATION OF PATIENT. AT FIRST RECOGNITION OF THE BREAK IN THE TUBING IN QUESTION, PATIENT PRESENTED WITH A SP02 OF 86%. PATIENT WAS DISCONNECTED FROM REVEL VENTILATOR AT THIS POINT. DECREASING PULSE RATE FOLLOWED WITH EVENTUAL BRADYCARDIC/PEA ARREST. HAD APPROXIMATELY 3 MINUTE PERIOD OF CARDIAC ARREST, CPR AND ADMINISTRATION OF 1 MG OF EPINEPHRINE WAS GIVEN BEFORE ROSC. UNAWARE OF WHAT THE CLINICAL STATUS IS OF THE PATIENT AT THIS TIME. PATIENT DEMOGRAPHICS (B)(6). A (B)(6) MALE. (B)(6)." FURTHER STATES "UNABLE TO PROVIDE LOT NUMBER AS THE PRODUCT WAS DISCARDED. ONLY HAS LOT NUMBER OF CURRENT SHIPMENT WHICH IS 153612, UNSURE IF IT IS THE SAME AS THE OTHER LOT NUMBER¿. THE CUSTOMER INDICATED THAT THE COMPLAINT DEVICE WAS NOT AVAILABLE FOR RETURN TO CAREFUSION FOR FURTHER EVALUATION. HOWEVER, AN INVESTIGATION WAS PERFORMED INTO THEIR REPORTED ISSUE. ALTHOUGH THE LOT NUMBER WAS UNKNOWN, LOT 153612 WAS THE LOT NUMBER OF THE CURRENT SHIPMENT RECEIVED BY THE FACILITY. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED FOR THIS LOT (153612). IT WAS CONFIRMED THAT THERE WERE NO ISSUES THAT OCCURRED DURING THE MANUFACTURE OF THIS LOT THAT MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE INJECTION PROCESS WAS REVIEWED FOR THE CAPS USED TO MANUFACTURE THIS LOT. ALL PARAMETERS AND DIMENSIONS WERE FOUND TO BE IN COMPLIANCE. THERE WERE NO ISSUES IDENTIFIED. A RANDOM SAMPLING OF CAPS WAS PERFORMED FROM ITEMS IN INVENTORY AND ALL WERE FOUND TO BE WITHIN DIMENSION. THE ASSEMBLY PROCESS WAS REVIEWED AND THERE WERE NO ISSUES IDENTIFIED. THE RETENTION SAMPLES FROM THIS LOT WERE FUNCTIONALLY TESTED. THIS FUNCTIONAL TESTING IS USED TO IDENTIFY LEAKING OF THE BREATHING CIRCUIT. A BROKEN NIPPLE WOULD CAUSE THE UNIT TO FAIL FUNCTIONAL TESTING. ALL OF THE RETENTION SAMPLES PASSED TESTING. WITHOUT THE ACTUAL COMPLAINT DEVICE AVAILABLE FOR EVALUATION THE EXACT ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL IS BEING FILED DUE TO A RETROSPECTIVE REVIEW OF MDR SUBMISSIONS. CORRECTIONS AND ADDITIONAL INFORMATION HAS BEEN COMPLETED. ADDITIONAL INFO. INVESTIGATION COMPLETION DATE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)- INITIAL EMDR SUBMISSION- THE ACTUAL PRODUCT THAT WAS INVOLVED IN THIS ISSUE IS NOT AVAILABLE FOR EVALUATION AS IT WAS DISCARDED BY THE END-USER. THE CUSTOMER WAS REQUESTED BY CUSTOMER ADVOCACY TO PROVIDE THE LOT NUMBER OF THE PRODUCT AND A REPRESENTATIVE SAMPLE. THE CUSTOMER STATED THAT THEY ARE UNABLE TO PROVIDE A LOT NUMBER AS IT IS UNKNOWN. HOWEVER, THEY DID PROVIDE A LOT NUMBER OF THE PRODUCT THAT THEY HAVE ON HAND WHICH IS 153612, THEY ALSO SUPPLIED A PHOTOGRAPH OF THE LABEL THAT THEY HAVE ON HAND. THE LABEL STATES IT WAS MADE IN (B)(6). AT THIS TIME STILL WAITING TO HEAR BACK FROM CUSTOMER REGARDING REPRESENTATIVE SAMPLE. IF A SAMPLE BECOMES AVAILABLE IT WILL BE EVALUATED. ALSO IF ANY ADDITIONAL INFORMATION BECOMES REGARDING THIS COMPLAINT OR WITH THE INVESTIGATION A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, ACCORDING TO THEIR TRANSPORT TEAM THE "NIPPLE PORTION OF THE PEEP BROKE" CAUSING A SERIOUS PROBLEM FOR THE PATIENT BEING VENTILATED. CUSTOMER STATED "HOSPITAL BED WITH PATIENT ON BOARD WAS LINED UP TO AIRCRAFT FOR LOADING OF PATIENT. THE REVEL VENT WAS BEING HELD BY HOSPITAL PERSONNEL AT HEAD OF PATIENT. PRIOR TO LOADING OF PATIENT IN AIRCRAFT, THE BROKEN TUBING IN QUESTION WAS FOUND. PATIENT WAS REMOVED FROM THE REVEL VENT AND VENTILATION WAS CONTINUED UTILIZING A SELF-INFLATING BAG W/PEEP VALVE. AN AUDIBLE VENT ALARM WAS NOT HEARD NOR SILENCED. UNAWARE IF ANY EXCESSIVE FORCE OR TUGGING OCCURRED ON THE CIRCUIT. THIS WAS A COMPLEX PATIENT WITH MULTIPLE LINES, TUBES, ETC. REQUIRING NUMEROUS PERSONNEL TO MOVE PATIENT FROM ICU TO HELIPAD. CRITICALLY ILL PATIENT WHO REQUIRED A HIGH FI02 (1.0), RESPIRATORY RATE (30), AND PEEP (18 CMH20) TO MEET OXYGENATION/VENTILATION REQUIREMENTS. CONCERN IS THAT A BREAK IN THE TUBING IN QUESTION RESULTED IN LOSS OF ALVEOLAR RECRUITMENT AND CLINICAL DETERIORATION OF PATIENT. AT FIRST RECOGNITION OF THE BREAK IN THE TUBING IN QUESTION, PATIENT PRESENTED WITH A SP02 OF 86%. PATIENT WAS DISCONNECTED FROM REVEL VENTILATOR AT THIS POINT. DECREASING PULSE RATE WAS NOTICED FOLLOWED WITH EVENTUAL BRADYCARDIC/PEA ARREST. HAD APPROXIMATELY 3 MINUTE PERIOD OF CARDIAC ARREST, CPR AND ADMINISTRATION OF 1 MG OF EPINEPHRINE WAS GIVEN BEFORE RETURN OF SPONTANEOUS CIRCULATION. UNAWARE OF WHAT THE CLINICAL STATUS IS OF THE PATIENT AT THIS TIME. UNABLE TO PROVIDE LOT NUMBER AS THE PRODUCT WAS DISCARDED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860565 ASSY PAT CIRC PEEPLESS ADULT SPU CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) CAI CAREFUSION 10822X10

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention