MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. BOMBA DE INFUSION PLUM 360 COMPATIBLE CON ICU MEDICAL MEDNET; PUMP, INFUSION

Catalog Number 300108813

Device Problem Infusion or Flow Problem (2964)

Patient Problems Cyanosis (1798); Hypoventilation (1916); Low Oxygen Saturation (2477); Respiratory Failure (2484)

Event Date 07/16/2020

Event Type  Injury  

Manufacturer Narrative

The device has been received for evaluation.Investigation is not complete.

Event Description

The event involved a plum 360 infusion pump.The plum 360 pump was programmed to infuse ketamine 250 mg in a 250 ml bag of saline with a final concentration of 1mg of ketamine per 1 ml.The infusion rate of 0.1mg/kg/hour based on a patient weight of (b)(6) kg was set to infuse at 6.8 ml/hour.The female patient was alert, conscious, orientated, and in a good general state with appropriate pain management prior to the event.The customer stated ¿infusing ketamine bolus, when changing the mixture in the pump, as a consequence respiratory depression, for which required support and transfer to icu¿.The patient desaturated, presented with oral cyanosis, became not responsive, and in respiratory arrest.Basic vital support was performed with an ambu bag with a satisfactory response.After the event, the patient fully recovered of the respiratory pattern and was cleared of the drug ketamine.The event did not prolong the hospital stay and there was no delay in therapy.

Manufacturer Narrative

H10: visual inspection of device is performed and found in good condition.A customer protocol is carried out in order to replicate any failure or error in the infusion system that generates an over-delivery of medication according to the customer experience.The device was programmed in channel a continuous mode to deliver a volume of 250 ml in 36 hours, 45 minutes at a flow rate of 6.8 ml / hr, resulting in 245 ml delivered in 36 hours 41 minutes 32 seconds.250 ml * 5% = (+ -12.5 ml) with a tolerance of +/- 5%, the delivery value was found in the allowed range.The delivery error margin was -5 ml.Based on customer experience, the device delivered the infusion in a ketamine bolus, but testing with the customer¿s protocol determined that the device worked 36 hours 41 minutes without interruption and with the infusion completed in channel a.The history of events shows that in the first initial programming carried out by the customer, the device was in autonomy to infuse correctly until it was stopped manually by the user.Free flow tests were performed and the mechanism was found to be able to open and close the cassette flow valve by means of the open regulator and closed regulator.Based on the information provided by the reporter and the results obtained during the investigation, there was no evidence of a malfunction or failure generated by the device.According to the protocol provided by the customer, a programming with the same flow and volume values was not found.The flow rate of 6.8 was found with different volumes.And the 250 ml volume was found but with another infusion rate.The probable cause was determined by history of events and was found user programming error.

• Brand Name: BOMBA DE INFUSION PLUM 360 COMPATIBLE CON ICU MEDICAL MEDNET
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 10420105
• MDR Text Key: 203384092
• Report Number: 9615050-2020-00189
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Public: ++M3353001088131D$$+741404949/16D20190626
• Combination Product (y/n): N
• PMA/PMN Number: K161469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 300108813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/18/2020
• Supplement Dates Manufacturer Received: 08/25/2020
• Supplement Dates FDA Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: KETAMINE, MFR UNK; KETAMINE, MFR UNK
• Patient Outcome(s): Required Intervention
• Patient Weight: 68