BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHUNT SENSOR SYS500

    MDR report key: 4234425 · Received October 31, 2014

    Report

    Report Number
    1124841-2014-00172
    Event Type
    Injury
    Date Received
    October 31, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 15, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON EVALUATION OF THE DEVICE THE COMPLAINT WAS NOT CONFIRMED. THE COMPLAINT SAMPLE WAS RETURNED AND VISUALLY INSPECTED UPON RECEIPT. MICROSCOPIC INSPECTION DID NOT DETECT ANY ANOMALIES. THE ACTUAL SAMPLE WAS THEN LEAK TESTED TO 1000MMHG FOR 30 SECONDS AND DID NOT LEAK. THE SAMPLE WAS ATTACHED TO A BPM HEAD AND PRESSURIZED TO 1000MMHG FOR 30 SECONDS. DURING THE ATTACHMENT OF THE BPM HEAD, THE BLUE ADAPTOR CAP WAS LOOSENED SLIGHTLY AND CAUSED THE UNIT TO LEAK. THE CAP WAS RE-TIGHTENED AND THE UNIT WAS TESTED AGAIN. NO LEAKS WERE NOTED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, BUT IT IS LIKELY THAT THE CAP BECAME LOOSE DURING SETUP AND CAUSED THE UNIT TO LEAK DURING USE. (B)(4). METHOD CODE #1: ACTUAL DEVICE EVALUATED. METHOD CODE #2: PERFORMANCE TESTS PERFORMED. METHOD CODE #3: VISUAL INSPECTION. METHOD #4: PRESSURE TESTING. RESULTS CODE: NO FAILURE DETECTED. CONCLUSIONS CODE: UNABLE TO CONFIRM COMPLAINT. ALL AVAILABLE INFO HAS BEEN PLACED ON FILE IN QUAL MGMT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP. (B)(4). LEVEL 5 CODE: (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORP THAT DURING CARDIOPULMONARY BYPASS THE SHUNT SENSOR LEAKED. ALTHOUGH THE PT'S AGE IS UNK, THE CASE IS ASSUMED TO BE PEDIATRIC DUE TO THE EVENT OCCURRING AT A PEDIATRIC HOSP. LESS THEN 1 CC OF BLOOD LOSS. PRODUCT WAS CHANGED OUT. SURGERY WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698677 SHUNT SENSOR SYS500 BLOOD-GAS MONITOR DRY TERUMO CARDIOVASCULAR SYSTEMS CORP. CDI510H UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other