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

Catalog Number 300100405

Device Problem Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/14/2023

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation, however, it is yet to be received.

Event Description

The event involved a plum 360 infusion pump which was reported to have shut off during patient infusion of an unspecified chemotherapy.There was patient involvement, however, no harm was reported as a consequence of this event.

Manufacturer Narrative

The device was received for evaluation on 5/19/2023.Evaluation performed was as follows: the device was plugged device into ac power and charged the battery for a minimum of 8 hours.Recharge start time is (b)(6) 2023 at 12:30 pm.Performed the battery operational checkout.Ran the device at a rate of 999 for a duration of 4 hours.Device passed the battery operational checkout.No battery-error alarms, or uncontrolled shut downs noticed during testing.Confirmed customer¿s complaint through review of the event alarm log history.Device has several battery-error alarms and uncontrolled shutdowns leading up to the reported incident and uncontrolled shut down events were present in the event alarm log history.Customer replaced the battery on (b)(6) 2023.Since the replacement of the battery by the customer, the device has experienced no more battery-error alarms, or uncontrolled shut down events.The customer resolved the complaint of uncontrolled shutdowns when they replaced the battery on (b)(6) 2023.Probable cause is the history is confirmed by review of the event/alarm logs, but not duplicated during physical testing.During inspection found the rear enclosure and cassette door to be damaged.Verified discrepancies through visual inspection.Replaced the rear enclosure and cassette door.Probable cause is physical damage consistent with normal wear and tear.By 17apr 07:21, the battery level was 4 and by 07:37:32 hr., the battery level was zero and the device issued a warning as depleted battery.Depleted battery is a high priority alarm which stops the infusion and prepares the pump for shutdown if not plugged into ac within 3 minutes after it is triggered.This is an improvement to detect batteries which are bad, that as soon as charged the power drops to depleted battery voltage.If the battery voltage drops below depleted voltage limit (5.45v) 3 times consecutively, it raises ¿n252 depleted battery¿ alarm.When the pump is in the depleted battery state, plugging in the pump to ac power allows the pump to be usable without shutting down.The ce shutdown message is sent after 1 minute in this state if ac is not connected.The battery employed by the plum 360 infuser is a sealed lead acid (sla) type rated at 6 volts dc and a current capacity of at least 4.5 ampere-hours.The typical battery operating time with a new and fully charged battery is 7 hours when infusing at 25 ml/hr, and 4 hours at 999 ml/hr¿ hence the infusion stopped, and the device shut down.By 19apr 09:57, the battery level was 4 and by 10:16:52 hr, the battery level was zero and the device issued a warning as depleted battery.There has been occurrence of depleted battery at 4 instances on 22apr, 26apr and 30apr.All alarms are raised within a short period of time once the battery level reached 4 and the device got switched to battery.After (b)(6) 2023 no occurrences of the depleted battery were found and the delivery was working as expected.In conclusion, the depleted battery alarm stops the infusions as it is the expected behavior and the device powered off, if not connected to ac main which is the expected behavior.The device depleted battery from level 4 to level 0 in less than 30 minutes in all the instances.This shows that the battery condition is not good.Engineering finds that there is repeated occurrence of the battery depleting abnormally fast and hence recommends replacement of battery.

• Brand Name: PLUM 360 DRIVER NEW
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 16894754
• MDR Text Key: 314819677
• Report Number: 9615050-2023-00127
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Public: ++M33530010040512$$+721770573/16D20160916
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 300100405
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED ADMINISTRATION SET, MFR UNK; UNSPECIFIED CHEMOTHERAPY, MFR UNK