BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM 360¿ INFUSER

    MDR report key: 14987445 · Received July 12, 2022

    Report

    Report Number
    9615050-2022-00138
    Event Type
    Malfunction
    Date Received
    July 12, 2022
    Date of Event
    June 20, 2022
    Report Date
    June 20, 2022
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K161469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS AVAILABLE FOR EVALUATION, HOWEVER HAS NOT BEEN RECEIVED. (B)(6).

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FOR EVALUATION ON AUGUST 1, 2022. ON (B)(6) 2022 DOWNLOADED THE CDA EVENT ALARM LOG HISTORY. SENT LOGS TO RESEARCH AND DEVELOPMENT (R&D). SALINE BAG LOT # 5604784. PRIMARY SET LIST # 14679-28 LOT # 5151926, SECONDARY SET LIST # 14229-28 LOT #5716951. SALINE BAG HAS APPROXIMATELY 3000 ML. PROGRAMMED DEVICE TO RUN A CONCURRENT PROTOCOL LINE A RATE OF 35 VOLUME TO BE INFUSED (VTBI) OF 200 FOR A DURATION OF 5 HOURS 49 MINUTES. LINE B WAS SET TO RUN AT RATE OF 465 ML/HR. VTBI OF 2999 FOR DURATION OF 6 HOURS 28 MINUTES. PROTOCOL WAS STARTED ON (B)(6) 2022 @ 12:20 PM. DEVICE ALARMED WITH PROXIMAL AIR LINE B, BACKPRIME (N231). THE DEVICE STOPPED DELIVERING. AIR NEVER REACHED THE DISTAL TUBING OF THE CASSETTE. PROBABLE CAUSE PUMP OPERATED PER DESIGN IT IS LIKELY THE CUSTOMER DID NOT UNDERSTAND THE DESIGNED TOLERANCES. DURING INVESTIGATION NO PHYSICAL DAMAGE OR EXCESSIVE CONTAMINATION WAS FOUND. SUMMARY OF R&D ANALYSIS ¿ENGINEERING EVALUATES THAT THE CUSTOMER¿S COMPLAINT OF UP TO ½ INCH OF DISTAL AIR WITHOUT ALARMING IS CONSISTENT WITH THE LOG DATA. HOWEVER, THE REPORTED QUANTITY OF DISTAL AIR IS (AT ABOUT 64 MCL) LESS THAN THE DESIGNED THRESHOLD FOR AIR DETECTION AND THE PUMP STOPPED THE INFUSION AT THAT POINT NORMALLY DUE TO THE PROGRAMMED VOLUME HAVING BEEN INFUSED. THE CUSTOMER¿S COMPLAINT IS CONFIRMED. HOWEVER, ENGINEERING EVALUATES THE PUMP OPERATED CORRECTLY PER DESIGN AND THE CUSTOMER LIKELY DID NOT UNDERSTAND THE DESIGNED TOLERANCES AND OPERATION OF THE PUMP AS REGARDS DETECTION OF DISTAL AIR¿. DEVICE LN 30010-04-81 (B)(6) . SINGLE LIST UDI. RECEIVED ONE (1) USED LIST #UNKNOWN PLUM SET FOR INSPECTION. THE SET WAS LEAK TESTED ACCORDING TO PRODUCT SPECIFICATIONS. NO LEAKS OBSERVED ANYWHERE ALONG THE FLUID PATH. THE PRODUCT WAS ATTACHED TO AN ICU MEDICAL PROVIDED IV BAG, PRIMED PER PACKAGING DIRECTIONS AND A FLOW TEST WAS PERFORMED USING THE RETURNED PLUM 360 INFUSER. THERE WERE NO DIFFICULTIES IN PRIMING, NO CASSETTE ERRORS, NO OCCLUSION ALARMS WERE GENERATED, NO AIR IN LINE ALARMS WERE GENERATED AND NO RESTRICTIONS IN FLOW WERE OBSERVED. NO AIR WAS OBSERVED IN THE FLUID PATH. TO REPLICATE CLINICAL USE, ANOTHER TEST INFUSION WAS PERFORMED WITH THE BAG AND FLUID PATH RUNNING DRY. BEFORE AIR FILLED THE CASSETTE THE PUMP STOPPED INFUSION AND GAVE ERROR PROXIMAL AIR BACKPRIME!!. THE REPORTED COMPLAINT OF THE AIR IN LINE PUMP ALARM NOT GOING OFF WAS UNABLE TO BE REPLICATED OR CONFIRMED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED FROM INVESTIGATION STATING: ADDING SUMMARY OF EXTENSIVE TESTING PERFORMED BY COSTA RICA RESEARCH AND DEVELOPMENT (R&D) TEAM, ¿BASED ON THE RESULTS OBTAINED FOR THE EXECUTED TESTING, NO OBJECTIVE EVIDENCE COULD BE FOUND OF ANY CONDITION RELATED TO PUMP FUNCTIONALITY THAT COULD BE DRIVING THE AIR IN LINE ISSUE. DISTAL AND PROXIMAL AIR VOLTAGE THRESHOLDS WERE FOUND INSIDE ACCEPTED RANGES. ALSO, BOTH MANKATO AND WENTWORTH-DOUGLASS PUMPS PASSED THE FINAL ACCEPTANCE TESTS RELATED TO AIR SENSORS. LIKEWISE, THE RESULTS OBTAINED FROM THE INFUSIONS RUNNING THE BAG DRY TRIALS DEMONSTRATE THAT THERE IS NO PUMP PATTERN TRIGGERING THE AIR IN LINE ISSUE.¿

    Description of Event or Problem · 0

    THE EVENT INVOLVED A PLUM 360 INFUSION PUMP, WHICH WAS REPORTED THE PUMP LET AIR ALL THE WAY THROUGH THE LINE WHERE AIR WAS DISTAL TO THE CASSETTE AND WITHOUT ALARM. THE ISSUE WAS RESOLVED WHEN THE TUBING WAS CHANGED OUT. THERE WAS NO STATUS CHANGE BEFORE, DURING, AND AFTER THE REPORTED ISSUE AND THERE WAS NO AIR INFUSED INTO THE PATIENT. THE INFUSION STARTED AT (B)(6) 2022 AT 14:16 P.M. THERE WAS 117 MLS IN SECONDARY FLUID IN THE BAG WHEN THE INFUSION WAS STARTED. THE CHAMBER WAS EMPTY AND FULL OF AIR AS WELL AS 1/2 INCH INTO TUBING EMPTY AND FULL OF AIR. THE RATE, VOLUME TO BE INFUSED (VTBI), AND DURATION OF INFUSION WAS 468/117/15 MINUTES. (B)(6) PROVIDED THE HISTORY/EVENT LOG: (B)(6) 2022-12:56:19-N234 DISTAL AIR. (B)(6) 2022-12:57:03-N101 NO ACTION ALARM (52). (B)(6) 2022-12:58:28-N234 DISTAL AIR. (B)(6) 2022-12:58:28-N101 NO ACTION ALARM (52). (B)(6) 2022-13:00:08-N251 CASSETTE TEST FAILURE. (B)(6) 2022-13:02:04-N161 LINE AVTBI COMPLETE. (B)(6) 2022-13:24:59-N58 LOW BATTERY. (B)(6) 2022-13:25:44-POWER SWITCHED: AC. (B)(6) 2022-13:27:03-POWER OFF. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772357 PLUM 360¿ INFUSER PUMP, INFUSION FRN ICU MEDICAL COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown FERUMOXYTOL, UNK MFR| NORMAL SALINE, UNK MFR| UNSPECIFIED PRIMARY TUBING, UNK MFR| UNSPECIFIED SECONDARY TUBING, UNK MFR