BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE RATED EXT SET BONDED SS 8.5

    MDR report key: 11646030 · Received April 9, 2021

    Report

    Report Number
    9616066-2021-50684
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 12, 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

    THE FOLLOWING FIELDS WERE CORRECTED: D10: DEVICE AVAILABLE FOR EVAL NO, D10: RETURNED TO MANUFACTURER ON: NA H1: DEVICE EVAL BY MANUFACTURER? NO H6: INVESTIGATION SUMMARY NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF FLOW ISSUES - FLUID BLOCKAGE COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL 22003E-07 BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. 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 TUBING WAS DEFECTIVE DURING USE AND WOULD NOT DRAW BLOOD. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD 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." "(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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRESSURE RATED EXT SET BONDED SS 8.5 TUBING WAS DEFECTIVE DURING USE AND WOULD NOT DRAW BLOOD. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD 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." "(B)(6) 2021 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
    542331 PRESSURE RATED EXT SET BONDED SS 8.5 INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 22003E-07 UNKNOWN 50885403242043

    Patients

    Seq Age Sex Outcome Treatment
    1