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

Catalog Number 300100413

Device Problems No Audible Alarm (1019); No Flow (2991); Unintended Application Program Shut Down (4032)

Patient Problems Cardiac Arrest (1762); Unspecified Respiratory Problem (4464)

Event Date 08/19/2023

Event Type  Injury  

Event Description

The event involved a plum 360 infusion pump.It was stated in the report that they had a recent medication safety event where a patient missed their norepinephrine and required intervention.Per the rn, the pump went dead (unknown time) and they did not realize it was not infusing.When they look at the event log, it appears that an alarm fired at 23:02 and was cleared prior to being powered off.The patient coded, but was successfully resuscitated.There was a delay in therapy and medical intervention was required to preclude harm to the patient as a result of the shutdown.The pump did not sound an audible tone prior to shutting down and there was a possible programming error.It appears that the pump may not have been programmed at all prior to the patient event and the medication was programmed on the new pump.Moreover, there was no damage noted in the power cord.Her original request was to review the pump report for her to determine if there was an issue with the battery.From her perspective, it appears that the norepinephrine was in standby and not infusing for hours prior to the event.She was unsure if there was a pump issue at all, but wanted to cover all bases with this investigation.An update was provided on 8-sep-2023 from the end user stating that they had an update to the investigation; the pump that was pulled for them to review was not the most recent pump used on this patient.Therefore, they do not have concerns with it and do not need to return the device.The pump involved is an icu medical pump, but they don¿t have the pump to be able to do an investigation.The wrong pump was pulled for them to investigate in the beginning and so they have no idea which pump was actually running on the patient when it died.They do not have any patient information on their pumps to be able to trace it back to this event.

Manufacturer Narrative

The wrong pump was pulled for them to investigate in the beginning and so they have no idea which pump was actually running on the patient when it died.The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.

Manufacturer Narrative

No device was returned to the service hub for analysis and evaluation.Therefore, no visual inspection and functional testing were performed to determine if the device played a role in the adverse event.The 12-month service history could not be reviewed as the customer did not provide the serial number of the pump.Icu medical reached out to the customer for the service repair history, but no information was provided.Event logs were provided.However, there is no confirmation whether or not these logs were pulled from the affected pump.The logs were evaluated to show due diligence of an event logs analysis.Analysis of mednet event/alarm log (eal) report for plum 15.10.00.012 serial # (b)(6).¿ 08/19: o 15:54:07 = power off.¿ 08/20: o 20:09:13 = power on.O 20:09:17 = line a: start ¿norepeinephrine (8 mg/250 ml)¿ for 200 ml @ 0.100 mcg/kg/min with weight 88.0 kg (16.5 ml/hr).O 20:11:10 = line a: titrate to 0.990 mcg/kg/min (163 ml/hr).O 20:16:19 = line a: titrate to 0.500 mcg/kg/min (82.5 ml/hr).O 20:18:56 = line a: titrate to 0.200 mcg/kg/min (33.0 ml/hr).O 20:19:01 = line a: titrate to 0.100 mcg/kg/min (16.5 ml/hr).O 20:21:40 = line a: placed in standby.Resumed @ 20:26:38.O 20:28:27 = line a: titrate to 0.200 mcg/kg/min (33.0 ml/hr).O 20:38:37 = line a: titrate to 0.240 mcg/kg/min (39.6 ml/hr).O 20:39:34 = line a: titrate to 0.300 mcg/kg/min (49.5 ml/hr).O 20:52:50 = line a: titrate to 0.400 mcg/kg/min (36.5 ml/hr).O 20:53:44 = line a: titrate to 0.500 mcg/kg/min (82.5 ml/hr).O 20:57:07 = line a: titrate to 0.400 mcg/kg/min (36.5 ml/hr).O 21:00:14 = line a: titrate to 0.300 mcg/kg/min (49.5 ml/hr).O 21:06:55 = line a: titrate to 0.400 mcg/kg/min (36.5 ml/hr).O 21:09:46 = line a: titrate to 0.500 mcg/kg/min (82.5 ml/hr).O 21:39:35 = line a: titrate to 0.560 mcg/kg/min (92.4 ml/hr).O 21:42:45 = line a: titrate to 0.400 mcg/kg/min (36.5 ml/hr).O 22:56:47 = line a: placed in standby.O 22:59:04 = pump raised n102 infuser idle 2 minutes alarm.O 23:02:03 = alarm cleared.O 23:02:45 = power off.¿ 08/21: o 18:30:04 = pump unplugged from ac main (to battery). this initial customer report appeared to have two parts: (1) the nurse¿s claim the pump went dead; and (2) michelle¿s statement of what she saw in the eal report for sn (b)(6).My review of the eal (sn (b)(6)) matches what michelle said she saw in the same eal report.We both agree that the sn (b)(6) did *not* show indication of dying or shutting itself down during infusion.Only of being placed in standby (a manual operation) and then alarming (for no user action) before being powered off (apparently manually).Given the customer¿s repeated statements that sn (b)(6) was *not* the correct pump and that the correct pump could not be identified by the customer, we can only conclude that we are unable to confirm the complaint that a pump (unknown serial #) died during an infusion leading to delay in therapy and patient harm.Conclusion: in conclusion, since the device was not returned to the service hub for analysis and evaluation, no visual inspection and functional testing were performed to determine if the device had a role in the adverse event.

• Brand Name: UNSPECIFIED PLUM 360 PUMP
• 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: 17778313
• MDR Text Key: 323786331
• Report Number: 9615050-2023-00455
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 300100413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: NOREPINEPHRINE, MFR UNK
• Patient Outcome(s): Life Threatening; Required Intervention