MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PLUM 360¿ INFUSER; PUMP, INFUSION

Catalog Number 300100483

Device Problems Failure to Infuse (2340); Pressure Problem (3012)

Patient Problems Cardiac Arrest (1762); Ventilator Dependent (2395); Respiratory Arrest (4461)

Event Date 03/01/2023

Event Type  Injury  

Manufacturer Narrative

The customer indicated that the device is not available for investigation.However, a comprehensive investigation has not yet been completed.

Event Description

The event occurred on an unspecified date and involved a plum 360¿ infuser.The reporter stated that the pump generated pressure alarms during an infusion of a critically ill infant weighing 5kg.Epinephrine from an infusion bag was infusing @ 1 ml/hr via the plum 360 pump.The peripheral intravenous (piv) would not infuse when connected to a bifuse with 0.5 ml/hr fentanyl.This critically ill infant was not receiving the epinephrine that was clinically required due to the pump issue.It was also stated that the pressure issue likely led to the patient coding because the patient was not receiving the vasopressor.Before the event occurred, the patient was brought to an outside hospital for cardiac arrest, and then was transferred to the initial reporter¿s end user facility.The patient was being transferred and still being stabilized during the complaint event.Cpr was subsequently started and the patient was also ventilated.The patient stabilized after the reported event.The amount of fluid in the bag when the issue was noted (and the amount of fluid that was expected to be remaining when the issue was noted) was unknown.Therapy for the patient resumed on a replacement (alaris) pump, since the plum 360 pump could not clear out the alarms.The reporter further complained that, in general, the icu medical pumps seem to be unable to infuse at low rates when connected to a bifuse or trifuse.The pressure backs up on one of the infusions causing high pressure alarms.

Manufacturer Narrative

Confirmed customer¿s complaint by review of eal error alarm logs.Device experienced several distal occlusion error alarms n192, n186 and n180 during infusion.Upon review of the device calibration data, the mechanism calibration was out of specification.The device passed self-testing and performance verification testing (pvt) with no error alarms.A series of distal occlusion stress tests were performed to duplicate customer¿s complaint.Programmed the device to run at an exceptionally low rate and check to see if the device is alarming appropriately for varying pressure settings.Stress test 1: rate = (b)(4).Volume to be infused (vtbi) of 5 ml set at a pressure of 1.2 psi device alarms appropriately with distal occlusion with a psi of 0.54 psi.Stress test 2: rate = (b)(4).Vtbi of 5 ml set at a pressure of 2.2 psi device alarms appropriately with distal occlusion with a psi of 1.76 psi.Stress test 3: rate = (b)(4).Vtbi of 5 ml set at a pressure of 3.2 psi device alarms appropriately with distal occlusion with a psi of 2.82 psi.Stress test 4: rate = (b)(4).Vtbi of 5 ml set at a pressure of 4.2 psi device alarms appropriately with distal occlusion with a psi of 3.88 psi.Stress test 5: rate = (b)(4).Vtbi of 5 ml set at a pressure of 5.2 psi device alarms appropriately with distal occlusion with a psi of 5.02 psi.The device passed the stress tests.The device also passed the distal occlusion pvt test.6 psi = 6.04 psi, 10 psi = 10.56 psi.The device passed the volume accuracy pvt test with 20.32 ml infused.Performed a customer¿s protocol line a (cca ¿peds 5.1-20 kg¿): started ¿epinephrine 20 mcg/ml¿ for 20.0 ml @ 1.2 mcg/kg/min (with weight 5.0 kg, calculates to 18.0 ml/hr.).The device passed the customer¿s protocol with a total vtbi of (b)(4).In conclusion, the device passed all testing and protocols.However, since the mechanism calibration data was out of specification, the mechanism was re-calibrated and passed.The device passed self-test with no error alarms.The calibration data is now within specifications.The distal pressure setting (set to 6.0 psi above) is the distal pressure threshold above which a distal occlusion alarm will be raised.The pump factory default value is 6.0 psi and this is user selectable within a range of 1.0 to 15.0 psi.The distal pressure threshold for this pump is currently set to the factory default.Increasing the threshold pressure may reduce the incidence of distal occlusion alarm stoppages.However, the optimal distal pressure threshold setting cannot be determined from the provided data.The customer¿s complaint of pressure buildups (occlusions) occurring and interrupting delivery of epinephrine is confirmed.The probable cause cannot be determined from the provided data.Further evaluation to ensure the pressure sensor is operating correctly per design is recommended by the complaint investigators.If and when this data/information becomes available, a supplemental emdr containing the new findings will be submitted at that time.Updated information can be found in d9.D9 - date returned to mfg: 16-may-2023.

Manufacturer Narrative

The complaint investigation was updated on 08/21/2023.Upon further evaluation, the slight discrepancy from a perfect calibration was insufficient to indicate that the device was out of specification.The device passed distal occlusion performance verification test (pvt) prior to calibration with results being 6 psi = 6.04 psi (acceptance range 3 - 9), and 10 psi = 10.56 psi (acceptance range 7 - 13).After calibration, the device also passed distal occlusion pvt test with 6 psi = 5.49 psi, and 10 psi = 9.2.The device passed the volume accuracy testing prior to calibration with 20.32 ml (acceptance range 19 - 21).The device passed the volume accuracy after calibration with 20.6 ml.The mechanism was calibrated for preventative reasons, and the device was still within calibration tolerances (within thresholds that were safe to use).Therefore, the update to the complaint investigation further supports that the pressure alarms reported by the customer were identified in the device history, however investigation did not confirm a defect or issue with the device.Device was functioning correctly.

• Brand Name: PLUM 360¿ INFUSER
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 16627687
• MDR Text Key: 312124967
• Report Number: 9615050-2023-00089
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 300100483
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: EPINEPHRINE, MFR UNK.; FENTANYL, MFR UNK.
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Weight: 5 KG