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

Catalog Number 300100405

Device Problem Inaccurate Flow Rate (1249)

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

Event Date 03/29/2023

Event Type  malfunction  

Event Description

The event involved a plum 360 in which the device failed the volume to be infused test.The device had pole clamp and speaker issues also; it sounds like the speaker is about to go out.There were no error messages and device is not alarming.The event occurred during testing, there was no patient involvement, no human harm, and no delay in therapy as a consequence of this event.This is report 2 of 2.

Manufacturer Narrative

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

Manufacturer Narrative

The device was received for evaluation on 4/29/2023.The customer's reported condition of unit failed volume to be infused test was confirmed.The device was tested per protocol with basic set up; device failed the performance verification test volume accuracy test.The fluid shield was replaced; device passed self-test with no error alarms.Device passed performance verification test volume accuracy test.Probable cause is damaged/defective fluid shield.

• 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: 16812200
• MDR Text Key: 314026876
• Report Number: 9615050-2023-00118
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Public: ++M33530010040512$$+721757896/16D20160315
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• 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: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1