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

Catalog Number 300100413

Device Problems Failure to Run on Battery (1466); Unexpected Shutdown (4019)

Patient Problems Intracranial Hemorrhage (1891); High Blood Pressure/ Hypertension (1908)

Event Date 01/26/2023

Event Type  malfunction  

Event Description

The event involved a plum 360¿ infuser.It was stated in the report that during ambulance transport the intravenous (iv) pump shut down without warning during a critical medication infusion.The pump had 3 bars indicating a good charge.A critically ill patient on medications to treat high blood pressure for a head bleed, without warning, pump battery failed and screen went blank.Patient became hypertensive.Upon arrival at the receiving hospital a new iv pump was found and patient was able to be stabilized.There was patient involvement and the patient with intracranial hemorrhage on medications to keep hypotensive, became hypertensive.Nurses reported that it took several minutes to resolve.

Manufacturer Narrative

The device is not available for evaluation, however the logs have been requested.Pending investigation.

Manufacturer Narrative

This is a general complaint, where no device was returned to the service hub for analysis and evaluation.Therefore, no visual inspection and functional testing were performed to determine if the device played a role in the adverse event.The 12-month service history could not be reviewed as the customer did not provide the serial number of the pump.Gcm reached out to the customer for the service repair history, but no information was provided.Event logs are not provided.Conclusion: in conclusion, since the device was not returned to the service hub for analysis and evaluation, no visual inspection and functional testing were performed to determine if the device had a role in the adverse event.

• Brand Name: PLUM 360¿ INFUSER
• 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: 16565753
• MDR Text Key: 312016663
• Report Number: 9615050-2023-00071
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 300100413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED MEDICATION, UNK MFR.