BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2860780 · Received December 5, 2012

    Report

    Report Number
    1828100-2012-01544
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER, POST PROCEDURE CLINICAL REVIEW AND LOG ANALYSIS REVEALED THE FOLLOWING RESULTS: DURING SETUP OF SYSTEM 1 AND THE CPB CIRCUIT, A PERFUSION A STUDENT HAD ACCIDENTALLY CHANGED THE GAS BLENDER OXYGEN (O2) BLEND TO 95-5 (INSTEAD OF THEIR USUAL AIR SETTING) ON THE ELECTRONIC PATIENT GAS SYSTEM (EPGS). THIS IS DONE VIA THE SET-UP TAB ON THE CENTRAL CONTROL MONITOR (CCM). IN ADDITION, THE STUDENT ACCIDENTALLY SET A LOW FIO2 ALARM BY TOUCHING THE LOW FIO2 ALARM BOX. THIS SET THE ALARM TO THE DEFAULT LEVEL OF 0.95 FIO2. THE STUDENT NOTICED THAT THEY HAD SET THE O2 BLEND TO 95-5 AND CHANGED THE O2 BLEND BACK TO THEIR USUAL SETTING: AIR. AFTER SETTING THE O2 BLEND BACK TO AIR, THE LOW FIO2 ALARM BOX DISPLAYED "---" AND THIS FOLLOWS VERBIAGE IN THE OPERATOR MANUAL OF THE SYSTEM 1 (THE FIO2 ALARM VALUES REVERT BACK TO NOT SET "---" IF THE BLENDING GAS SELECTION IS CHANGED). INVESTIGATION IN PROCESS, BUT NOT YET COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE (CPB), THE USER WAS GETTING AN UNEXPECTED LOW FRACTIONATED OF INSPIRED OXYGEN (FIO2) ALARM ON THE ELECTRONIC PATIENT GAS SYSTEM (EPGS). THE EPGS WAS CALIBRATED SUCCESSFULLY AND THERE WERE NO ISSUES WITH THE GAS SYSTEM FOR THE REMAINDER OF THE SET-UP PERIOD. THE DEVICE WAS NOT CHANGED OUT. THE PROCEDURE WAS COMPLETED, AS SCHEDULED. THERE WAS A DELAY OF ABOUT FIVE MINUTES, AT THE ONSET OF CPB, AS THE EPGS LOW FIO2 ALARM ISSUE WAS BEING ASSESSED AND DURING THE EPGS RE-CALIBRATION. THERE WAS NO LOSS OF BLOOD ASSOCIATED WITH THIS INCIDENT AND NOTHING WAS CHANGED OUT. THOUGH THE PATIENT WAS HYPOXIC AND HYPERCAPNIC DURING THE SEVENTY-FIVE TO EIGHTY SECOND IPGS CALIBRATION PERIOD OF NO OXYGENATOR GAS FLOW, THERE WERE NO SIGNS OF PATIENT HARM INTRA-OPERATIVELY OR POST-OPERATIVELY DUE TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEM CORP 801188

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO