BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLM A+ SPANISH DEVICE REMAN RESTART

    MDR report key: 21973204 · Received May 6, 2025

    Report

    Report Number
    9615050-2025-00205
    Event Type
    Injury
    Date Received
    May 6, 2025
    Date of Event
    April 7, 2025
    Report Date
    June 5, 2025
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FRN
    UDI-DI
    718449580
    PMA / PMN Number
    K070398
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION, HOWEVER, OUR INVESTIGATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN DUE COURSE.

    Additional Manufacturer Narrative · 0

    THE PUMP WAS RETURNED FOR COMPLAINT INVESTIGATION. LABEL INSPECTION - PASS. AC POWER CORD INSPECTION, AC CORD RETAINER INSPECTION: PASS. FRONT CASE AND REAR CASE: PASS. CASSETTE DOOR: PASS. DOOR LEVER: PASS. DOOR ROLLER INSPECTION AND TEST: PASS. FLUID SHIELD INSPECTION: PASS. DISTAL PRESSURE SENSOR INSPECTION: PASS. PROXIMAL PRESSURE SENSOR INSPECTION: PASS. RUBBER FOOTS INSPECTION: FAIL 2 FOOTS MISSING POLE CLAMP INSPECTION AND TEST: PASS. KEYPAD INSPECTION: PASS. DISPLAY AND INDICATORS INSPECTION: PASS. KEYPAD LOCKOUT SWITCH INSPECTION: PASS. THE VISUAL INSPECTION WAS PERFORMED AND THE DEVICE WAS FOUND TO BE IN NORMAL CONDITION, MISSING ONLY 2 FEET, BUT THIS DOES NOT AFFECT ITS FUNCTIONALITY. DEVICE DATE AND LOCAL DATE: DEVICE DATE AND TIME: (B)(6) 2025, 4:39 PM. LOCAL DATE AND TIME: (B)(6) 2025, 5:09 PM. THE DEVICE WAS FOUND WITH THE CORRECT DATE, BUT THE TIME WAS 30 MINUTES LESS. PLEASE NOTE THAT THE INVESTIGATION WILL BE CONDUCTED USING THE TIME FOUND ON THE DEVICE. THUS, THE ACTUAL TIME OF EACH EVENT WILL BE CALCULATED BY 30 MINUTES FOR EACH HOUR MENTIONED IN THE ANALYSIS. EVENT HISTORY INTERPRETATION: THE EVENT HISTORY WAS DOWNLOADED FROM THE DEVICE AND FOUND A PROGRAMMING START ON (B)(6) 2025, AT 10:01 PM PUMP TIME: CHANNEL: A. VOLUME TO BE INFUSED (VTBI): 500 ML. INFUSION RATE: 120 ML/HR. DURATION: 4 HOURS 10 MINUTES (SEE EVENT NUMBERS 78 TO 72). AT 11:08 PM, THIS INFUSION WAS STOPPED BY THE USER. UP TO THIS POINT, IT HAD INFUSED 132,9 ML OF THE PROGRAMMED 500 ML IN A TIME OF 1 HOUR 7 MINUTES. (SEE EVENTS 71, 70, AND 69). AT THE SAME TIME, 11:08 PM, THE DEVICE WAS TURNED ON BY THE USER (SEE EVENT NUMBER 68) TO PROGRAM THE FOLLOWING INFUSION: CHANNEL: A. VOLUME TO BE INFUSED (VTBI): 400 ML. INFUSION RATE: 1.2 ML/HR. DURATION: 333 HOURS 20 MINUTES (SEE EVENT NUMBERS 57 TO 51). AT 11:13 PM, THE DEVICE WAS STOPPED AND TURNED OFF BY THE USER; THE INFUSION DID NOT DELIVER ANY MEDICATION. (SEE EVENT NUMBERS 49 AND 48). AT 11:22 PM, THE DEVICE WAS TURNED ON AND A NEW INFUSION WAS PROGRAMMED WITH THE FOLLOWING VALUES: CHANNEL: A. VOLUME TO BE INFUSED (VTBI): 500 ML. INFUSION RATE: 8.2 ML/HR. DURATION: 60 HOURS 58 MINUTES (SEE EVENT NUMBERS 36 TO 30). ON (B)(6) 2025, AT 11:05 A.M., THE DEVICE WAS STOPPED AND TURNED OFF BY THE USER. UP TO THIS POINT, 96.2 ML HAD BEEN INFUSED IN 11 HOURS AND 43 MINUTES. (SEE EVENTS 15 AND 14). ANALYSIS, SUMMARY, AND CONCLUSIONS OF THE EVENT HISTORY: ACCORDING TO CUSTOMER EXPERIENCE, THE SUPERVISOR OBSERVED A DRIP AT 120 ML/HR BETWEEN 11:00 P.M. AND MIDNIGHT ON (B)(6) 2025. ACCORDING TO THE EVENTS FOUND, IT IS EVIDENT THAT THIS RATE WAS PROGRAMMED, WITH A DELIVERY OF 133 ML IN 1 HOUR AND 7 MINUTES FROM 22:01 TO 23:08 P.M. (PUMP TIME) (22:31 TO 23:38 REAL TIME). THE USER THEN STOPPED THE INFUSION TO PROGRAM A NEW ONE, CHANGING THE FLOW RATE FROM 120 ML/HR TO 1.2 ML/HR. HOWEVER, THIS INFUSION DID NOT DELIVER ANY MEDICATION BECAUSE IT WAS STOPPED BY THE USER. THE CUSTOMER ALSO REPORTS A LACTATED RINGER'S INFUSION AT 8.2 ML/HR. THIS INFUSION IS ALSO FOUND IN THE EVENTS, DELIVERING 96.2 ML OF THE PROGRAMMED 500 ML. PROTOCOL CUSTOMER TESTING: INFUSION START: DATE: (B)(6) 2025. TIME: 9:14. CHANNEL: A. VOLUME TO BE INFUSED (VTBI): 6 ML. INFUSION RATE: 1.2 ML/HR. DURATION: 5 HOURS. END OF INFUSION: DATE: (B)(6) 2025. END TIME: 14:16. TOTAL VOLUME INFUSED (VI): 6.2 ML. TOTAL INFUSION TIME: 5 HOURS 2 MINUTES. CONCLUSION OF CUSTOMER PROTOCOL TESTING. THE DEVICE WAS PROGRAMMED ON CHANNEL A TO DELIVER A VOLUME OF 6 ML IN 5 HOURS AT A FLOW RATE OF 1.2 ML/HR, RESULTING IN 6.2 ML DELIVERED IN 5 HOURS 2 MINUTES. 6 ML * 5% = (+/- 0.3 ML) WITH A TOLERANCE OF +/- 5%. THE DELIVERY VALUE WAS WITHIN THE ALLOWABLE RANGE. THE DELIVERY ERROR MARGIN WAS + 0.2 ML. CUSTOMER PROTOCOL TESTING DETERMINED THAT THE DEVICE OPERATED FOR 5 HOURS WITHOUT INTERRUPTION AND THE INFUSION WAS COMPLETED WITHOUT OVERDELIVERY OR ALTERATIONS IN THE VALUES, DELIVERING AS PROGRAMMED. A KEYBOARD TEST WAS PERFORMED TO VERIFY THAT IT WAS NOT SELF-PROGRAMMING. EACH KEY WORKED CORRECTLY, AND THE TEST PASSED. PROBABLE CAUSE: THE 120 ML/HR SETTING MENTIONED BY THE CUSTOMER WAS EVIDENT. THIS IS ATTRIBUTED TO A USER ERROR DURING PROGRAMMING, DUE TO THE SETTING OF A SPEED HIGHER THAN REQUIRED FOR THIS MEDICATION. ADDITIONAL INFORMATION CAN BE FOUND IN B2 AND B5. CORRECTED INFORMATION CAN BE FOUND IN B7, D4, D7A.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A PLM A+ SPANISH DEVICE REMAN RESTART WHERE THE CUSTOMER REPORTED THAT IT WAS EVIDENT THAT THE MEDICATION VALUES, PRESCRIBED BY THE DOCTOR DID NOT MATCH THE PROGRAMING BEING INFUSED BY THE PUMP. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE PEDIATRIC SERVICE, COMING FROM THE OPERATING ROOM, DUE TO RESPIRATORY DIFFICULTY, FOR WHICH THEY PROCEEDED TO PERFORM AN OROTRACHEAL INTUBATION ADJUSTED TO INVASIVE MECHANICAL VENTILATION. MEDICATION PRESCRIBED WAS: INTRAVENOUS FLUIDS DEXTROSE 10% 8.2 CC / H, MORPHINE 15 MCG / KG / HOUR, INCREASE FROM 1 AMP TO 10CC WITH DEXTROSE, FROM THIS MIXTURE TAKE 1 CC AND INCREASE TO 24 CC, INCREASE 1 CC / HOUR, TITRATABLE BETWEEN 0.6-1.3 CC / HOUR. DOSE: 10-20 MCG / KG / HOUR. DURING THE NIGHT SHIFT, BETWEEN APPROXIMATELY 11:00 PM AND 12:00 AM, THE SHIFT SUPERVISOR OBSERVED THAT THE INFUSION PUMP WAS INFUSING THE DEXTROSE 10% AT A DRIPPING RATE OF 120 CC/H. THE INFUSION WAS SUSPENDED, AND THE PEDIATRICIAN AND PHYSICIANS WERE NOTIFIED. THE PATIENT PRESENTED A METABOLIC DISORDER AND WAS AT RISK DUE TO THE INFUSION, HENCE THE PATIENT WAS REFERRED TO ANOTHER LEVEL OF COMPLEXITY. AS A MEDICAL INTERVENTION THE HOSPITAL DISCONTINUED THE DEXTROSE AND STARTED RINGER'S LACTATE AT 8.2 CC/H UNTIL BLOOD GLUCOSE LEVELS WERE NORMAL. THE EVENT OCCURRED DURING A MALE PATIENT USE, PATIENT'S FATHER'S INITIALS GR, 5 HOURS OLD, 50 CM HEIGHT, 2840 GRAMS OF WEIGHT, THERE WAS HARM REPORTED. THE PATIENT WAS REFERRED FROM THE INSTITUTION IN POOR GENERAL CONDITION, MAKING IT NOT POSSIBLE TO DETERMINE WHETHER ANY PERMANENT DAMAGE HAD OCCURRED; AT THE TIME OF THE INQUIRY, THE PATIENT REMAINED IN THE NEONATAL CARE UNIT AND HAD NOT FULLY RECOVERED. ADDITIONAL INFORMATION IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN DUE COURSE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION FROM THE CUSTOMER WAS RECEIVED ON 07-MAY-2025 STATING THAT: THE NEONATE PRESENTED SEVERE PULMONARY HYPERTENSION AND PASSED AWAY ON (B)(6) 2025 AT THE INSTITUTION. REGARDING THE BLOOD GLUCOSE LEVELS, THEY WERE 118 MG/DL BEFORE THE PROCEDURE, 529 MG/DL DURING THE PROCEDURE, AND 372 MG/DL AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1831710 PLM A+ SPANISH DEVICE REMAN RESTART PUMP, INFUSION FRN ICU MEDICAL COSTA RICA LTD. 718449580

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Male Life Threatening| R DEXTROSE, MFR UNK.| MORPHINE, MFR UNK.