MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. ENGLISH FOR CANADA, PLUM 360¿ INFUSER COMPATIBLE WITH ICU MEDICAL MEDNET¿ SOFTWA; PUMP, INFUSION

Catalog Number 300106513

Device Problems Failure to Deliver (2338); Unexpected Shutdown (4019)

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

Event Date 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation; however, testing has not yet been completed.

Event Description

It was reported that, on an unknown date, a plum 360 experienced an immediate uncontrolled shutdown during a patient infusion.There was no patient harm reported.

Manufacturer Narrative

Complaint "of immediate uncontrolled shutdown" was confirmed when trying to perform the cassette test and the device alarmed n56 (replace battery) however when the alternate current (a/c) was disconnected the device powered off, also found this alarm in the alarm history logs.The probable cause is the battery.The battery was replaced and the cassette test with ac power or direct current (dc) power only was performed.All relevant performance verification testing (pvt) passed with no alarm or error codes.

• Brand Name: ENGLISH FOR CANADA, PLUM 360¿ INFUSER COMPATIBLE WITH ICU MEDICAL MEDNET¿ SOFTWA
• 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: 16634522
• MDR Text Key: 312321670
• Report Number: 9615050-2023-00092
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Public: ++M33530010651318$$+743403490/16D20181117
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K161469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 300106513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1