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

Catalog Number 300100413

Device Problems Insufficient Flow or Under Infusion (2182); Infusion or Flow Problem (2964)

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

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

Confirmed customer¿s complaint of device had a delivery accuracy issue.Tested device by running delivery accuracy test per performance verifcation test (pvt).Device failed with under delivery of 19.6.Review of device alarm log history found error code e380-plunger failure, was present.Replaced pwa driver board, app board, pressure detector sensor, fluid shield.Calibrated mechanism.Mechanism passed calibration.Device passed delivery accuracy test with 20.8.Devie passed self-test with no error alarms.Probable cause is worn pwa driver board, app board, pressure detector sensor.Additional initial reporter phone number: (b)(6).

Event Description

The event occurred on an unspecified date and involved a plum 360¿ infuser where it was stated that the pump is constantly alarming.It was reported the pump is under and over outputting.The issue was discovered in the biomed shop.There was no patient involvement and there was no patient harm.

• 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: 18867929
• MDR Text Key: 337245238
• Report Number: 9615050-2024-00221
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Public: ++M33530010041311$$+743426153/16D20190405
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 300100413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2019
• 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