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

Catalog Number	300100483
Medical Device Problem Codes	No Audible Alarm (1019); Alarm Not Visible (1022); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.If additional information becomes available a supplemental report will be submitted.
Event or Problem Description
The event involved a plum 360¿ infuser where the reporter stated that they noticed bubbles inside the plum cassette and along the tubing line (going to patient).The alarm did not go off, so i back primed it to remove the bubbles, and i removed the bubbles in the tubing line (going to patient) with a syringe.No fluid bubbles were infused to the patient, no harm done to the patient.Per manufacturer's product info: the air trap in the plum cassette can capture up to 1 ml of air before alarming, if an air-in-line alarm does occur, air can be easily removed with automated back priming without disconnecting from the patient.The issue is the icu medical plum 360 pump is its inability to detect the fluid bubbles in the plum cassette and was able to pass thru the plum cassette to the tubing line going to the patient; posing a hazard/ risk to have these fluid bubbles go to patient's blood.There was patient involvement and no patient harm.

• Brand Name: PLUM 360¿ INFUSER
• 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: 20695133
• Report Number: 9615050-2024-00845
• Device Sequence Number: 6583641
• Product Code: FRN
• UDI-Device Identifier: M3353001004141
• UDI-Public: M3353001004141
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Report Date (Section B): 11/15/2024

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: 300100483
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLUM CASSETTE, MFR UNK; TUBING, MFR UNK
• Patient Sex: Unknown