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

Catalog Number 300100413

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2023

Event Type  malfunction  

Event Description

The event involved a plum 360 infusion pump.It was reported that at 23:01 a nurse sent an order for diltiazem to the pump.Shortly after, the bag was found empty with the patient receiving the entire bag in mere minutes.The screen of the pump showed the prior programming from hours earlier.The reporter stated that he could not replicate how the pump could receive programming, reject it, and still retain the prior programming from before it was last powered off.At 23:01 the prior programming had drug library settings that would allow the new programming to interrupt it.There was patient involvement, there was patient harm or adverse event reported and there was delay in therapy.

Manufacturer Narrative

The device is not available for investigation.However, device logs will be evaluated, but the evaluation is not yet complete.

Manufacturer Narrative

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.Engineering evaluates the pump performed correctly per design.The auto program was rejected automatically by the pump due to the auto programmed drug being defined as non-interruptible while there was a programmed piggyback infusion defined on line b.This rejection was correct as per the plum design requirements.The clinician pressed [start] following the ap auto-rejection which had the effect of restarting the existing (iv fluid bolus @ 500 ml/hr) line a program, instead of the rejected (diltiazem at 50 ml/hr) auto program.This was correct pump behavior as the ap had been rejected.The pump delivered accurately as programmed within design tolerance.Engineering evaluates the probable cause of the bag running dry was user error: specifically, the clinician having loaded a 100 ml bag of diltiazem (less priming volume) and then restarting the program for iv fluid bolus.The customer is aware of the cause and has confirmed satisfaction with the explanation and resolution.

• 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: 16666914
• MDR Text Key: 312600665
• Report Number: 9615050-2023-00100
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 300100413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2023
• Initial Date FDA Received: 04/03/2023
• Supplement Dates Manufacturer Received: 05/08/2023
• Supplement Dates FDA Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: DILTIAZEM, UNK MFR