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

Catalog Number	300102905
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date and involved a plum 360 infusion pump where it was reported replacement of the cover + battery, and the flow rate is non-compliant.The status of the product at the time of event is unknown.There was unknown patient involvement, unknown adverse event/human harm.
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.
Additional Manufacturer Narrative
Engineering confirms that the infusion got interrupted by multiple occlusion and valve cassette test failure alarms which was tried clearing by back priming, power cycles and opening the cassette door.But the alarms continued to occur.Hence engineering recommends service centre to do the preventive maintenance tests.Apart from this, engineering confirms that the device was working as expected performance verification test: the device failed proximal occlusion test due to triggering n190(proximal occlusion) prematurely.The pressure detector and app pwa were replaced and device recalibrated and passed pvt testing.The complaint is not confirmed.Probable cause: replacement of the cover + battery and the flow rate is non-compliant - not confirmed as not confirmed through log review and not replicated during testing.No probable cause determined device has a damage fluid shield ¿ damaged fluid shield.

• Brand Name: PLUM 360 DRIVER FRENCH
• 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: 20863008
• Report Number: 9615050-2024-00876
• Device Sequence Number: 8592159
• Product Code: FRN
• UDI-Device Identifier: M3353001004141
• UDI-Public: M3353001004141
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K161469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2025

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: 300102905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown