BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE RATED EXT SET BONDED SS 8.5

    MDR report key: 11646027 · Received April 9, 2021

    Report

    Report Number
    9616066-2021-50685
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 13, 2021
    Report Date
    May 4, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    50885403242043
    PMA / PMN Number
    K051499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY TWO SAMPLES (MODEL 22003E-07) WERE RETURNED BY THE CUSTOMER. IT WAS REPORTED THAT THE ITEM WAS NOT ALLOWING A BLOOD DRAW. THE SETS WERE EXAMINED FOR DEFECTS AND ABNORMALITIES. NO DEFECTS OR ABNORMALITIES WERE OBSERVED. THE SAMPLES WERE CONNECTED TO A CUT OFF SYRINGE TIP TO CHECK THAT THE FLUID PATH IS IN AN ACTIVATED POSITION/OPEN WHEN CONNECTED TO A SYRINGE. THE SAMPLES WERE THEN FLUSHED WITH WATER TO CONFIRM AN OPEN FLUID PATH. THE FLUID PATHS OF TWO SAMPLES WERE OPEN AND THOSE SAMPLES WERE ABLE TO BE FLUSHED. THE FAILURE WAS UNABLE TO BE REPLICATED, AND THE COMPLAINT COULD NOT BE VERIFIED. A DEVICE HISTORY RECORD REVIEW FOR MODEL 22003E-07 LOT NUMBER 20109558 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON (B)(6) 2020. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. A ROOT CAUSE WAS UNABLE TO BE DETERMINED. A TREND FOR THIS OCCLUSION ISSUE HAS BEEN IDENTIFIED FOR THIS PRODUCT LINE. A CAPA (CORRECTIVE ACTION PREVENTATIVE ACTION) 1998036 HAS BEEN INITIATED, AND A TEAM HAS BEEN ASSEMBLED IN ORDER TO INVESTIGATE THE ISSUE. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRESSURE RATED EXT SET BONDED SS 8.5 WAS BLOCKED/OCCLUDED AND SET OFF A "HIGH PRESSURE READING" WHEN ATTEMPTING TO POWER INJECT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE HAD ANOTHER PROBLEM WITH DIFFERENT PATIENT I BELIEVE IT WAS ON (B)(6) 9TH. THE PROBLEM I HAD WITH THAT PATIENT WAS I HAD THE J-LOOP ATTACHED TO MY VACUTAINER AND HAD STARTED MY IV AND WAS ATTACHING THE J-LOOP AND COULD NOT GET IT TO DRAW BLOOD. THEN I REMOVED THE VACUTAINER ATTACHMENT AND TRIED TO PUSH SALINE THROUGH IT TO REATTACH IT AND IT WOULD NOT EVEN ALLOW ME TO PUSH SALINE THROUGH IT. I REMOVED THE SALINE FLUSH AND REATTACHED IT THINKING I DID NOT HAVE IT SCREWED ON CORRECTLY AND IT STILL WOULD NOT ALLOW ME TO FLUSH TUBING. I THEN HAD TO CALL FOR ANOTHER J-LOOP THIS ONE FUNCTIONED APPROPRIATELY, I WAS ABLE TO DRAW BLOOD AND FLUSH WITHOUT PROBLEMS. I HAVE HAD OTHER NURSES TELL ME THEY HAVE HAD ISSUES BUT I DO NOT KNOW THEIR ISSUES. I A LOT OF WHAT I HAVE HEARD IS THAT THE TUBING IS TOO STIFF TO BE COMFORTABLE FOR THE PATIENTS. WE START MOST OF OUR IV¿S IN THE AC AND THE TUBING MAKES IT UNCOMFORTABLE. FOR EVENT #2, #3, #4 ¿ I HAD STARTED THE IV, CONNECTED MY J-LOOP WITH VACUTAINER ATTACHED AND WAS ABLE TO BLOOD WITHOUT ANY PROBLEMS, I THEN WAS ABLE TO FLUSH THE LOCK WITHOUT PROBLEMS. IT IS WHEN THE PATIENT WENT TO CT-SCAN AND THE TRIED TO POWER INJECT THAT IT GAVE THEM A ¿HIGH PRESSURE READING¿ AND WAS UNABLE TO COMPLETE THE TEST UNTIL WE CHANGED THE LOOP BACK TO THE OLD LOOP I GOT FROM ANOTHER FLOOR." "(B)(6) 21 0015 ATTEMPTING TO START AN IV AND DRAW BLOOD FROM IV START WHEN THE J-LOOP WOULD NOT DRAW BLOOD AND I UNHOOKED AND REATTACHED VACUTAINER TO J-LOOP AND ALSO FROM ANGIO HUB TOOK OFF AND REATTACHED AND STILL WOULD NOT DRAW BLOOD."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRESSURE RATED EXT SET BONDED SS 8.5 WAS BLOCKED/OCCLUDED AND SET OFF A "HIGH PRESSURE READING" WHEN ATTEMPTING TO POWER INJECT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE HAD ANOTHER PROBLEM WITH DIFFERENT PATIENT I BELIEVE IT WAS ON MARCH 9TH. THE PROBLEM I HAD WITH THAT PATIENT WAS I HAD THE J-LOOP ATTACHED TO MY VACUTAINER AND HAD STARTED MY IV AND WAS ATTACHING THE J-LOOP AND COULD NOT GET IT TO DRAW BLOOD. THEN I REMOVED THE VACUTAINER ATTACHMENT AND TRIED TO PUSH SALINE THROUGH IT TO REATTACH IT AND IT WOULD NOT EVEN ALLOW ME TO PUSH SALINE THROUGH IT. I REMOVED THE SALINE FLUSH AND REATTACHED IT THINKING I DID NOT HAVE IT SCREWED ON CORRECTLY AND IT STILL WOULD NOT ALLOW ME TO FLUSH TUBING. I THEN HAD TO CALL FOR ANOTHER J-LOOP THIS ONE FUNCTIONED APPROPRIATELY, I WAS ABLE TO DRAW BLOOD AND FLUSH WITHOUT PROBLEMS. I HAVE HAD OTHER NURSES TELL ME THEY HAVE HAD ISSUES BUT I DO NOT KNOW THEIR ISSUES. I A LOT OF WHAT I HAVE HEARD IS THAT THE TUBING IS TOO STIFF TO BE COMFORTABLE FOR THE PATIENTS. WE START MOST OF OUR IV¿S IN THE AC AND THE TUBING MAKES IT UNCOMFORTABLE. FOR EVENT #2, #3, #4 ¿ I HAD STARTED THE IV, CONNECTED MY J-LOOP WITH VACUTAINER ATTACHED AND WAS ABLE TO BLOOD WITHOUT ANY PROBLEMS, I THEN WAS ABLE TO FLUSH THE LOCK WITHOUT PROBLEMS. IT IS WHEN THE PATIENT WENT TO CT-SCAN AND THE TRIED TO POWER INJECT THAT IT GAVE THEM A ¿HIGH PRESSURE READING¿ AND WAS UNABLE TO COMPLETE THE TEST UNTIL WE CHANGED THE LOOP BACK TO THE OLD LOOP I GOT FROM ANOTHER FLOOR." "3/13/21 0015 ATTEMPTING TO START AN IV AND DRAW BLOOD FROM IV START WHEN THE J-LOOP WOULD NOT DRAW BLOOD AND I UNHOOKED AND REATTACHED VACUTAINER TO J-LOOP AND ALSO FROM ANGIO HUB TOOK OFF AND REATTACHED AND STILL WOULD NOT DRAW BLOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542333 PRESSURE RATED EXT SET BONDED SS 8.5 INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 22003E-07 20109558 50885403242043

    Patients

    Seq Age Sex Outcome Treatment
    1