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

Catalog Number 300100413

Device Problem Failure to Deliver (2338)

Patient Problems Cardiac Arrest (1762); Respiratory Arrest (4461)

Event Date 02/01/2023

Event Type  Injury  

Manufacturer Narrative

Although the device was requested to be returned for evaluation, it has not been received.

Event Description

The event involved an unspecified plum 360 infusion pump that occurred on an unspecified date.The customer reported that a patient came into the emergency department and was placed on a pump.During transportation to the icu, the pump died and the patient coded.The staff was able to get the patient stabilized using another pump.There is no more information pertaining to this event available at this time.

Event Description

The customer provided the following information on (b)(6) 2023: the reporter became aware of the issue during a conversation that was not formally recorded as a complaint at the facility.However, the reporter has provided all available information at this time.Although the exact date of the event is unknown, it occurred approximately 2-3 months ago.The patient was being transferred from the er to icu on the elevator when the pump died.The er staff quickly moved the patient from the elevator to the icu and staff from both departments began to convert the patient to pumps in icu.Before that could be completed, the patient coded.The staff was able to quickly get a pulse back and effectively take care of the patient.The pump¿s battery was dead.The delay in therapy was estimated to be 1-2 minutes, and medical interventions were made using advanced cardiovascular life support (acls) protocol.The patient¿s status prior the event was stable.During the event, patient had cardiac arrest and after the event, patient was stabilized and treated.Although the er staff was present during the event, they were unsure if the pump sounded an audible tone prior to powering off.

Manufacturer Narrative

Additional information can be found in b5 and h6 (health effect - impact code).Correction can be found in d4 - expiration date null.

Manufacturer Narrative

Although multiple attempts were made requesting the pump to be returned for investigation, the device was not returned.Therefore, no visual inspection and functional testing were able to be 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: 16537029
• MDR Text Key: 311219521
• Report Number: 9615050-2023-00057
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Public: ++M33530010041311$$+7/16D
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 300100413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2023
• 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
• Patient Outcome(s): Life Threatening; Required Intervention