BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASE SYSTEM,ILLUMENA,NON-OEM

    MDR report key: 12576070 · Received October 5, 2021

    Report

    Report Number
    1518293-2021-00027
    Event Type
    Malfunction
    Date Received
    October 5, 2021
    Date of Event
    September 8, 2021
    Report Date
    September 8, 2021
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    DXT
    PMA / PMN Number
    K963071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    OVERALL INVESTIGATION SUMMARY: GUERBET WAS NOTIFIED OF A COMPLAINT BY A CUSTOMER ON INJECTOR PRODUCT 900006 SN (B)(4) ALLEGING THE SYRINGE WAS GETTING BLOOD BACK INTO THE SYRINGE. THE CUSTOMER WANTED THE PRESSURE CALIBRATION TO BE VERIFIED. IT WAS ALSO REPORTED THAT THE 150ML PRESSURE SLEEVE WAS CRACKED AND THAT THE CUSTOMER WAS EXPERIENCING BLOW BY ISSUES. FSE INSPECTED THE SYSTEM, CONFIRMING A CRACK ALONG THE LENGTH OF THE PRESSURE SLEEVE, REPLACED THE 150 ML PRESSURE SLEEVE. FSE ALSO REPLACED A MISSING SLEEVE BEARING ON THE 150 ML FACEPLATE. FSE THEN POWERED UP THE INJECTOR AND GOT AN ERROR 2003. UPON INVESTIGATION, IT WAS FOUND THE ERROR WAS DUE TO CONTRAST THAT HAD GOTTEN ONTO THE LINER POT IN THE POWER HEAD FROM CONTRAST SPILLS DUE TO REPORTED BLOW BY OF THE SYRINGE. FSE CHOSE TO REPLACE THE LINEAR POT TO CLEAR THE ERROR, INSTEAD OF CLEANING IT. THEN FSE CLEANED THE POWERHEAD OF CONTRAST. THE PRESSURES WERE THEN TESTED AND FOUND TO BE WITHIN SPECIFICATION. FSE DID NOT CONFIRM BLOOD IN THE SYRINGE ISSUE. BLOOD IN THE SYRINGE IS USUALLY A CASE OF BACK PRESSURE. IF THE INJECTOR HITS A PRESSURE LIMIT HARD OR EVEN STALLS, THERE CAN BE A SIGNIFICANT AMOUNT OF BACK PRESSURE CREATED IN THE CATHETER AND BLOOD CAN BE PUSHED BACK UP THE CATHETER AND INTO THE SYRINGE WHEN THE MOTOR RELAXES. FSE VERIFIED OPERATION OF THE CLEANED SYSTEM ACCORDING TO SERVICE CHECKLIST 9001001 AND THE UNIT WAS RETURNED TO CUSTOMER USE. THERE WAS NO INJURY TO PATIENT OR STAFF. BLOW-BY IS A SITUATION IN WHICH THE CONTRAST GETS PAST THE SEALS OF THE PLUNGER AND CAN LEAK OUT THE BACK SIDE OF THE PLUNGER. IF THE INJECTOR IS THEN TILTED UP AFTER THIS OCCURS, THE CONTRAST THAT HAS GOTTEN BEHIND THE PLUNGER CAN FLOW DOWN ALL OVER THE INJECTOR HEAD. THE PRESSURE SLEEVE IS DESIGNED AS A BARRIER TO PREVENT THE SYRINGE FROM BREAKING UNDER HIGH PRESSURE. THE INJECTOR OPERATIONS MANUAL WARNS USER TO CHECK THE PRESSURE SLEEVE DAILY BEFORE USE FOR ANY CRACKS THAT MAY HAVE DEVELOPED IN THE SLEEVE. SINCE THIS PRESSURE SLEEVE HAD A LARGE CRACK, IT WAS THUS COMPROMISED. A COMPROMISED PRESSURE SLEEVE MIGHT NOT ADEQUATELY CONTAIN THE SYRINGE AND POSSIBLY ALLOW IT TO 'EXPAND' DURING HIGH PRESSURE. THIS EXPANSION OF THE DIAMETER OF THE SYRINGE COULD ALLOW CONTRAST TO LEAK PAST (BLOW-BY) THE PLUNGER AS IT NO LONGER HAS A GOOD SEAL ON THE SIDES OF THE SYRINGE. IT IS UNKNOWN HOW THE PRESSURE SLEEVE WAS CRACKED TO THIS DEGREE. TECH SUPPORT STATED THAT, IN THE PAST, SOMETHING LIKE THIS HAS ONLY OCCURRED IF THE FACEPLATE WAS DROPPED OR OTHERWISE STRUCK REPEATEDLY AND INTENTIONALLY. A REVIEW OF GUERBET COMPLAINT TRACKING SYSTEM (CTS) SHOWED NO RELATED COMPLAINT ACTIVITY FOR THIS DEVICE. -IMPACT ASSESSMENT SUMMARY NO INJURY TO PATIENT OR STAFF (B)(4). ROOT / PROBABLE CAUSE CODE EQUIPMENT/INSTRUMENT - FAILURE ROOT / PROBABLE CAUSE SUMMARY: REFER TO INVESTIGATION SUMMARY. NO FURTHER INVESTIGATION NEEDED AT THIS TIME. QA WILL CONTINUE TO MONITOR AND TREND FOR SIMILAR ISSUES. NO CAPA AT THIS TIME, THESE TRENDS AND ISSUES ARE REPORTED ON DURING QUALITY METRICS REVIEW AND DURING THE MANAGEMENT REVIEW MEETINGS TO CONSIDER INPUT FOR CORRECTIVE ACTION. DISPOSITION SUMMARY: UNIT RETURNED TO CUSTOMER USE.

    Description of Event or Problem · 0

    THIS INCIDENT WAS REPORTED BY A FACILITY IN (B)(6) ON (B)(6) 2021. THE CUSTOMER REPORTED THAT THE SYRINGE IS GETTING BLOOD BACK IN TO THE SYRINGE AND ADVISED THAT THE SLEEVE HAD A BUNCH OF CRACKS IN IT, THINKING IT MIGHT BE RELATED TO THE FACEPLATE OR PRESSURE SLEEVE. THE REPORTER STATES THAT THE EVENT OCCURRED DURING A PROCEDURE, AND THAT THE PROCEDURE WAS COMPLETED WITH NO INJURY TO PATIENT OR STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1471959 BASE SYSTEM,ILLUMENA,NON-OEM BASE SYSTEM,ILLUMENA,NON-OEM DXT LIEBEL-FLARSHEIM 900006 C0420C351G

    Patients

    Seq Age Sex Outcome Treatment
    1