BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM 360 DRIVER NEW

    MDR report key: 16365978 · Received February 13, 2023

    Report

    Report Number
    9615050-2023-00031
    Event Type
    Malfunction
    Date Received
    February 13, 2023
    Date of Event
    January 15, 2023
    Report Date
    January 20, 2023
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K161469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT ON (B)(6) 2023, BETWEEN 2-3 AM, EPIC¿S VOLUME CALCULATOR WAS OBSERVED TO BE REPORTING DIFFERENT VOLUMES THAT THE PUMP AUTO DOCUMENTATION SPECIFIED FOR SIX PUMPS (PLUM SERIAL #S (B)(6), (B)(6), (B)(6), (B)(6), (B)(6), AND (B)(6)). THE SPECIFICS OF THE DISCREPANCIES WERE ONLY PROVIDED FOR THE LAST 3 OF THE FORMERLY LISTED PUMPS. ENGINEERING AND TECH SUPPORT INVESTIGATED AND DETERMINED THE PROXIMATE CAUSE OF THE DISCREPANCY WAS THAT AUTO DOCUMENTATION MESSAGES FROM PUMPS TO EPIC (WHEN PASSED THROUGH MEDNET TO EPIC VIA MIRTH) ARE STAMPED WITH THE TIME THE MIRTH MESSAGE IS PROCESSED. IN THIS INSTANCE, THE CUSTOMER EXPERIENCED A NETWORK OUTAGE AROUND THIS TIME WHICH RESULTED IN A DELAY OF MESSAGES BEING SENT BY MIRTH TO EPIC. EPIC IS CURRENTLY CONFIGURED TO USE ITS PROCESSING TIME AS THE TIMESTAMP FOR THE AUTO DOCUMENTATION MESSAGE INDICATING THE TIME OF THE EVENT. THUS, THE DELAY OF PROCESSING RESULTED IN AN INCORRECT TIME WHICH EPIC USED IN CALCULATING INFUSION DURATION AND, HENCE, VOLUME. IT WAS DECIDED TO CONFIGURE MIRTH TO USE THE PROCESSING TIME, RATHER THAN THE TIME PROVIDED BY THE PUMP. THIS WAS PREDICATED ON A KNOWN ISSUE IN THE PLUM PUMP WHERE THE CE MAY DRIFT OVER TIME. ENGINEERING EVALUATED THAT THE ISSUE WAS ATTRIBUTABLE TO THE PLUM PUMP, SPECIFICALLY A PLUM CE CLOCK DRIFT ISSUE SYNC CE SYSTEM TIME TO RTC. THIS SOFTWARE ISSUE HAS BEEN FIXED IN CE 4.0 AND IS EXPECTED TO BE INCORPORATED IN A FUTURE RELEASE OF THE PLUM PUMP.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED. ADDITIONAL CONTACT: (B)(6).

    Description of Event or Problem · 0

    THE EVENT INVOLVED A PLUM 360¿ INFUSER THAT THE CUSTOMER REPORTED A DISCREPANCY BETWEEN THE VOLUME REPORTED TO EPIC (THEIR HOSPITAL INFORMATION SYSTEM) AND THE VOLUME SHOWING (AS INFUSED) ON THE PUMP. AT THE TIME OF COMPLAINT REGISTRATION, THE CUSTOMER DID NOT HAVE ANY SPECIFIC VOLUME OR EXAMPLE, BUT THEY INDICATED THAT IT MIGHT BE ONLY A FEW MILLILITERS. THE CUSTOMER STATED THAT THE DISCREPANCY WOULD NOT BE CLINICALLY SIGNIFICANT WITH EXCEPTION ONLY TO NEONATAL USE CASES. THE EVENT OCCURRED DURING INFUSION USING THE INTEGRATED WORKFLOW WITH AUTO PUMP PROGRAMMING AND IT OCCURRED DURING THE 0200-0300 HOUR. EPIC REPORTED ALL PUMPS IN QUESTION WERE OFFLINE AT SOME POINT BETWEEN 01:47 AND 02:07. THE NURSE CAUGHT THE VOLUME DISCREPANCY. WITHIN EPIC, THE CUSTOMER STATED THAT THEY HAVE TWO ACTIVITIES FOR SUGGESTED INFUSED VOLUMES; THE VOLUME CALCULATOR AND THE INFUSION VERIFY ACTIVITIES. THESE TWO ACTIVITIES DISPLAYED DIFFERENT INFUSED AMOUNTS FOR THE 0200-0300 HOUR. THE CUSTOMER HAS CONTACTED EPIC, WHO IS STILL INVESTIGATING, BUT THEY BELIEVE THE VOLUME CALCULATOR WAS DISPLAYING ACCURATELY WHAT THE PUMP WAS SENDING BUT THIS WAS NOT CONGRUENT WITH WHAT THE NURSE AND SYSTEM SAYS WAS THE RUNNING RATE. THE FOLLOWING INFORMATION WAS ADDITIONALLY PROVIDED BY THE CUSTOMER: FWPPLM0517, A PRIMARY- NEONATAL 2-IN-1 TPN (START (B)(6) 22:57:05 END (B)(6) 20:24:35). THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THIS REPORTED EVENT. SUBSEQUENT TO ACK1 AND ACK2 PASSING THROUGH THE FDA GATEWAY FOR THE ORIGINAL EMDR (EMDR-07103 THAT FAILED FOR ACK3), THE FOLLOWING INFORMATION WAS RECEIVED FROM THE CUSTOMER: IT WAS DETERMINED AT THE FACILITY THAT THERE WAS NOT AN ISSUE WITH THE PUMPS THEMSELVES, CONVERSELY, THERE WERE ISSUES PERTAINING TO THE MESSAGES THAT WERE SENT INTO THE HOSPITAL'S EPIC SYSTEM. TO THE CUSTOMER'S KNOWLEDGE, THE PUMPS HAD NOT BEEN SEQUESTERED OR SENT FOR REPAIR AND EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1653765 PLUM 360 DRIVER NEW PUMP, INFUSION FRN ICU MEDICAL COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown EPIC HOSPITAL INFORMATION SYSTEM (HIS), MFR UNK| TPN, MFR UNK