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

Catalog Number	300100413
Medical Device Problem Code	Application Program Problem: Dose Calculation Error (1189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.
Event or Problem Description
It was reported that a plum 360 experienced an infusion dosage change during patient use.The report stated that when the customer paused the pump and then resumed, the pump changed the dosage.The reported issue was not related to physical damage.There was patient involvement, no harm, and a delay in therapy.No additional information is available at this time.
Additional Manufacturer Narrative
Self-test passed.Visual inspection performed and found small crack on the front case.The customer complaint wasn't confirmed that the device did have any issue with the pump being pause and then after resuming, the pump change dosage.During protocol of running of piggyback on line a and line b, along with pausing and switching back and forth on the each lines.The pump didn't have any issues with running or performing the dosage.The probable cause wasn't found, no issues.Cosmetic on the front case.Engineering summarizes: two auto programs (with manual titrations) were run with the same medication over the 2 days & 17 hours between power on (the evening on (b)(6), and power off (the afternoon on (b)(6).The 1st auto program (¿drug id: 796 (50 mg/250 ml)¿ for 250 ml @ dose 20.0 mcg/min) ran for 40 hours with 17 titrations (ranging between the dosages of 10.0 & 40.0 mcg/min) before being superseded by the 2nd auto program.O the 2nd auto program (¿drug id: 796 (50 mg/250 ml)¿ for 250 ml @ dose 20.0 mcg/min) ran for 25 hours with 15 titrations (ranging between the dosages of 15.0 & 75.0 mcg/min) before being aborted manually by user action.Leading up to the aborting of the infusion on (b)(6), the infusion had been over the course of about 1 minute: 1.Placed in standby (by pressing [standby] [yes]).2.Resumed from standby (by pressing [start] [yes]).3.Placed in standby (by pressing [standby] [yes]).4.Resumed from standby (by pressing [start] [yes]).5.Stopped (by pressing [a] [stop]).6.Restarted (by pressing [return to a/b] [start]).7.Placed in standby (by pressing [standby] [yes]).8.And, finally, the pump was simply powered off (by pressing [on_off]).Analysis of all delivery segments over the last day (on (b)(6) showed the pump was delivering accurately within design tolerance (+/- 5.0% by volume).Engineering evaluates that the logs showed the pump dosage only changing when either (a) an auto program was accepted; or (b) when a new dose was manually entered by logged keypresses.The logs showed no change in the infused dosage at the time of the several pausing's of the infusion.The customer¿s complaint could not be confirmed.Based on the logged data, the pump is operating correctly as designed.

• Brand Name: PLUM 360
• Common Device Name: 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: 19933715
• Report Number: 9615050-2024-00579
• Device Sequence Number: 2736247
• Product Code: FRN
• UDI-Device Identifier: M3353001004131
• UDI-Public: M3353001004131
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 300100413
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown