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

Catalog Number	400020401
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number (sn) displayed was not in customer inventory.Screen shows (b)(6) and barcode label reads (b)(6).The field service engineer (fse) factory defaulted and corrected sn to reflect correct sn shown on label.No performance verification test (pvt) or device history report (dhr) required.
Event or Problem Description
The event involved a plum duo infusion system where it was reported that the device serial number show on screen does not match serial number on barcode label during implementation/configuration of device.There was no patient involvement and no patient harm.

• Brand Name: PLUM DUO INFUSION SYSTEM
• 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: 20858850
• Report Number: 9615050-2024-00873
• Device Sequence Number: 11731475
• Product Code: FRN
• UDI-Device Identifier: M335400021
• UDI-Public: M335400021
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223607
• 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
• Type of Report: Initial
• Report Date (Section B): 12/05/2024

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: 400020401
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2024
• 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