BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACE MEDICAL AF W/AS 550 X 1-14ML/HR CPNB

    MDR report key: 7404361 · Received April 6, 2018

    Report

    Report Number
    3004365956-2018-00092
    Event Type
    Injury
    Date Received
    April 6, 2018
    Date of Event
    March 1, 2018
    Report Date
    March 16, 2018
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    MEB
    PMA / PMN Number
    K090300
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). THE CUSTOMER RETURNED ONE (1) AUTOFUSER, CATALOG NUMBER MVBLX-CPNB, AF W/AS 550 X 1-14ML/HR CPNB (LOT A150715-PSCFB000US-1). VISUAL INSPECTION OF THE RETURNED AUTOFUSER REVEALED THAT THE INSIDE OF THE PUMP WAS DRY; THE AUTO-SELECTOR WAS SET AT 6ML/HR; THE DIAL SELECTOR WAS REMOVED FROM THE AUTO-SELECTOR; THE BALLOON WAS EMPTY; DISENGAGED TUBING CLAMP WAS PLACED BETWEEN THE AUTO-SELECTOR AND THE FILTER AND; A TUBING EXTENSION WAS ATTACHED TO THE MALE LUER AND A NON-TELEFLEX EPIDURAL CATHETER WAS ATTACHED TO THE END OF THE TUBING EXTENSION. FUNCTIONAL TESTING WAS PERFORMED ON THE RETURNED PAIN PUMP. AFTER EMPTYING FOR SIXTY-SIX (66) HOURS, APPROXIMATELY 405ML OF FLUID FLOWED THROUGH THE TUBING. PER THE INSTRUCTIONS FOR USE (IFU), THE FLOW RATE ACCURACY IS ¿15% OF THE LABELED NOMINAL RATE RESERVOIRS WHEN FLOWING AT STANDARD CONDITIONS. (CON'T). OTHER REMARKS: THE NOMINAL RATE RESERVOIR IS 6ML/HR, THEREFORE, THE SPECIFICATION OF THE FLOW RATE IS 5.1ML - 6.9ML. THE AVERAGE FLOW RATE IS 6.14ML/HR. THEREFORE, THE FLOW RATE SETTING OF 6ML/HR IS 5.22ML - 7.06ML. THE FUNCTIONAL TESTING PASSED THE FLOW RATE SET AT 6ML/HR FOR 66 HOURS IS WITHIN ¿15% OF THE LABELED NOMINAL RATE. BECAUSE THE PUMP DID NOT EMPTY IN 12 HOURS, A SECOND FUNCTIONAL TEST WAS PERFORMED ON THE NON-TELEFLEX EPIDURAL CATHETER. A LEAK TEST WAS PERFORMED USING A LAB REFERENCE SNAPLOCK AND THE NON-TELEFLEX EPIDURAL CATHETER. THE TEST METHOD USED IS INTENDED FOR ARROW BRANDED CATHETERS AND IS THEREFORE FOR REFERENCE ONLY. THE PROXIMAL END OF THE NON-TELEFLEX EPIDURAL CATHETER WAS INSERTED INTO THE LAB REFERENCE SNAPLOCK ADAPTER UNTIL IT BOTTOMED OUT AND THE INSERTION POINT WAS MARKED. THE NON-TELEFLEX EPIDURAL CATHETER WAS CONFIRMED TO BE FULLY SECURED TO THE LAB REFERENCE SNAPLOCK ADAPTER BY TUGGING GENTLY. THE LAB REFERENCE SNAPLOCK ADAPTER WAS THEN CONNECTED TO THE LEAK TESTER AND FLOW WAS ESTABLISHED AT 10 PSI. LEAKS WERE OBSERVED FROM THE PROXIMAL END OF THE NON-TELEFLEX EPIDURAL CATHETER. THE DISTAL END OF THE NON-TELEFLEX EPIDURAL CATHETER WAS CAPPED OFF WITH A LAB REFERENCE SNAPLOCK ADAPTER AND THE PRESSURE WAS INCREASED TO 25 PSI FOR 30 SECONDS AND WATER SPRAYED FROM A HOLE ON THE PROXIMAL END OF THE NON-TELEFLEX EPIDURAL CATHETER. THE HOLE FROM THE PROXIMAL END OF THE NON-TELEFLEX EPIDURAL CATHETER IS NOT A COMPONENT DEFECT. THE PUNCTURED HOLE IN THE CATHETER IS AUTOMATICALLY SEALED REDUCING CHANCE FOR LEAKAGE AND DISLOCATION. THE CATHETER IS PLACED INSIDE OF THE LUER CONNECTION AND THEN THE GREEN HUB IS ATTACHED TO THE LUER LOCK. THE PROXIMAL END OF THE CATHETER DOES NOT LEAK WHEN COVERED WITH THE GREEN HUB. THE REPORTED COMPLAINT THAT THE PUMP RELEASED ALL OF THE MEDICATION IN 12 HOURS COULD NOT BE CONFIRMED THROUGH FUNCTIONAL INSPECTION. DURING THE FUNCTIONAL INSPECTION, THE AUTO-SELECTOR WAS SET AT 6ML/HR. AFTER 66 HOURS, APPROXIMATELY 405ML OF FLUID EMPTIED THROUGH THE TUBING. PER THE IFU, THE FLOW RATE ACCURACY IS ¿15% OF THE LABELED NOMINAL RATE RESERVOIR WHEN FLOWING AT STANDARD CONDITIONS. BASED ON THE SPECIFICATIONS OF THE IFU, THE FLOW RATE SET AT 6ML/HR FOR 66 HOURS IS WITHIN ¿15% OF THE LABELED NOMINAL RATE. DURING THE FUNCTIONAL INSPECTION, NO DESTRUCTIVE TESTING WAS PERFORMED ON THE PAIN PUMP. BASED ON THE RESULTS OF THE INVESTIGATION THAT THE PAIN PUMP DID NOT EMPTY ALL OF THE MEDICATION IN 12 HOURS AND THE MEASURED FLOWRATE WAS WITHIN SPECIFICATION, THEREFORE, NO FUNCTIONAL ISSUES FOUND.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT ALLEGES "THE PAIN PUMP WAS SUPPOSED TO LAST FROM (B)(6) 2018. WHEN WE GOT HOME ON (B)(6) 2018, THE PUMP WAS WORKING AND GIVING HER RELIEF FROM THE PAIN. HOWEVER, SHE WOKE UP IN THE MIDDLE OF THE NIGHT, FEELING EXTREMELY DIZZY AND NAUSEOUS. I HAD HER TRY TO MAKE IT THROUGH THE NIGHT. IN THE MORNING, SHE SAID SHE FELT EVEN WORSE. SHE HAD CHEST PAINS, A HEADACHE, A METAL TASTE IN HER MOUTH, ITCHY SKIN, DIZZINESS AND NAUSEA. I LOOKED AT THE PAIN PUMP AND WE REALIZED THAT THE ENTIRE PUMP WAS EMPTY. THE MEDICATION THAT SHOULD HAVE LASTED 48 TO 72 HOURS ADMINISTERED AUTOMATICALLY ON ITS OWN WITHIN LESS THAN 12 HOURS! WE CONTACTED THE ANESTHESIOLOGIST AND HE ADVISED US TO GO THE ER. PATIENT DISCHARGED HOME AFTER 5 HOURS OF OBSERVATION. IT WAS REPORTED THAT THE PATIENT HAS RECOVERED FROM HER SYMPTOMS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVOLVED IN THIS COMPLAINT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT. THE INVESTIGATION INTO THIS COMPLAINT IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "THE PAIN PUMP WAS SUPPOSED TO LAST FROM (B)(6) 2018 UNTIL (B)(6) 2018. WHEN WE GOT HOME ON (B)(6) 2018, THE PUMP WAS WORKING AND GIVING HER RELIEF FROM THE PAIN. HOWEVER, SHE WOKE UP IN THE MIDDLE OF THE NIGHT, FEELING EXTREMELY DIZZY AND NAUSEOUS. I HAD HER TRY TO MAKE IT THROUGH THE NIGHT. IN THE MORNING, SHE SAID SHE FELT EVEN WORSE. SHE HAD CHEST PAINS, A HEADACHE, A METAL TASTE IN HER MOUTH, ITCHY SKIN, DIZZINESS AND NAUSEA. I LOOKED AT THE PAIN PUMP AND WE REALIZED THAT THE ENTIRE PUMP WAS EMPTY. THE MEDICATION THAT SHOULD HAVE LASTED 48 TO 72 HOURS ADMINISTERED AUTOMATICALLY ON ITS OWN WITHIN LESS THAN 12 HOURS! WE CONTACTED THE ANESTHESIOLOGIST AND HE ADVISED US TO GO THE ER. PATIENT DISCHARGED HOME AFTER 5 HOURS OF OBSERVATION. IT WAS REPORTED THAT THE PATIENT HAS RECOVERED FROM HER SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246024 ACE MEDICAL AF W/AS 550 X 1-14ML/HR CPNB PUMP, INFUSION, ELASTOMERIC MEB TELEFLEX MEDICAL A150715-PSCF

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization