BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASE SYSTEM,ILLUMENA,NON-OEM

    MDR report key: 7826626 · Received August 29, 2018

    Report

    Report Number
    1518293-2018-00028
    Event Type
    Malfunction
    Date Received
    August 29, 2018
    Date of Event
    August 1, 2018
    Report Date
    August 1, 2018
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    DXT
    PMA / PMN Number
    K963071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    OVERALL INVESTIGATION SUMMARY: BIOMED CALLED LF SERVICE TO ORDER A NEW PRESSURE SLEEVE. DURING THE DISCUSSION BIOMED TOLD TECH SUPPORT THAT DURING A CASE, THE BARREL PORTION OF THE 150 ML PRESSURE SLEEVE (P/N 900450), WHICH IS PART OF THE 150 ML FACEPLATE, BROKE AT THE FLANGE AND SEPARATED FROM THE REST OF THE PRESSURE SLEEVE. BIOMED DID NOT KNOW THE TECHNIQUE (FLOW RATE/PRESSURE LIMIT) BEING USED AT THAT TIME AND DID NOT KNOW HOW FAR THE BARREL OF THE PRESSURE SLEEVE HAD MOVED AFTER IT BROKE FROM THE FLANGE. NEITHER THE PATIENT NOR STAFF WAS AFFECTED. THE BIOMED NOTED THAT THE INJECTOR WAS 12 YRS OLD AND THOUGHT THAT THE PRESSURE SLEEVE WAS THE ORIGINAL ONE. BIOMED STATED TO TECH SUPPORT THAT HE BELIEVED THAT THE PRESSURE SLEEVE BROKE BECAUSE IT WAS OLD. THE ILLUMENA OPERATIONS MANUAL (PN 900955) SEC 6 MAINTENANCE STATES A WARNING INSTRUCTING THE USER TO DO A DAILY INSPECTION OF PRESSURE SLEEVE FOR STRESS MARKS OR CRACKS AS THE USE OF SUCH PARTS MY CAUSE INJURY OR AN ABORTED INJECTION. THERE HAVE BEEN NO KNOWN CASES REPORTED WHERE THE BARREL HAS SEPARATED FROM THE FLANGE OF THE PRESSURE SLEEVE. LAST LF SERVICE TO THIS UNIT WAS REPORTED IN 2014.

    Description of Event or Problem · 1

    INITIAL NOTIFICATION ON (B)(6) 2018 OF INCIDENT DESCRIBED AS DURING INJECTION, THE PRESSURE SLEEVE/FACEPLATE BLEW RIGHT OFF THE END (TUBE SECTION BLEW OFF END). REPORTER STATED THAT THE FLANGE PORTION OF THE 150 ML PRESSURE SLEEVE, P/N 900450, WHICH IS PART OF THE 900490 150 ML FACEPLATE, BROKE OFF, AND SEPARATED FROM THE REST OF THE PRESSURE SLEEVE. HE DOES NOT KNOW WHAT TECHNIQUE (FLOW RATE OR PRESSURE LIMIT) THEY WERE RUNNING. HE SAID THAT THE PATIENT WAS NOT AFFECTED AND THAT HE WILL ORDER THE PRESSURE SLEEVE. FOLLOW-UP CALL WAS MADE TO REPORTER ON 14 AUGUST 2018, AND REPORTER STATED THAT THEY RECEIVED THE NEW 150 ML PRESSURE SLEEVE AND ARE CURRENTLY USING THE INJECTOR WITHOUT ISSUE. REPORTER STATS THAT HE WAS NOT THERE AT THE TIME OF THE INCIDENT AND SO COULD NOT COMMENT ON HOW MUCH THE BARREL OF THE PRESSURE SLEEVE MOVED WHEN IT BROKE OFF OF THE FLANGE, BUT HE KNOWS THAT NEITHER THE PATIENT NOR ANYONE ELSE WAS INJURED. REPORTER STATES THAT IT IS UNKNOWN WHY THE PRESSURE BROKE, AND THAT IT SHOULD BE NOTED THAT THE INJECTOR IS 12 YEARS OLD AND THE REPORTER BELIEVES THE FACEPLATE PRESSURE THAT BROKE IS THE ORIGINAL TO THE INJECTOR. REPORTER STATES THAT HE BELIEVED THE PRESSURE SLEEVE BROKE BECAUSE IT WAS OLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666523 BASE SYSTEM,ILLUMENA,NON-OEM BASE SYSTEM,ILLUMENA,NON-OEM DXT LIEBEL-FLARSHEIM 900006

    Patients

    Seq Age Sex Outcome Treatment
    1