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 Problem Unexpected Shutdown (4019)

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

Event Date 05/01/2023

Event Type  malfunction  

Manufacturer Narrative

The complaint of " device turns off and on" was confirmed.Probable cause is defective , non-icu medical approved battery.Battery error n56 was also seen in the history.After new battery was installed, the device passed all relevant performance verification tests (pvt) successfully.

Event Description

The incident involved a plum 360 infusion pump on an unknown date.The reporter stated that the pump intermittently turns on and off.There was unknown patient involvement and unknown patient harm.

• 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: 16938513
• MDR Text Key: 315362088
• Report Number: 9615050-2023-00135
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Public: ++M33530010651318$$+743462214/16D20191212
• 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
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• 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: 05/12/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1