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

Catalog Number 300100413

Device Problem Use of Device Problem (1670)

Patient Problem Seizures (2063)

Event Date 06/12/2020

Event Type  Injury  

Manufacturer Narrative

The serial number of the device is unknown and it is unknown if the device will be returned for evaluation.Without the return of the device a comprehensive failure investigation cannot be performed, and a cause cannot be determined.

Event Description

A user facility mandatory medwatch ((b)(4)) was received on 24-aug-2020 which stated the following: ¿concerns with icu plum pump with no safety alarm built into the system to alert nursing staff to restart pump when placed on standby mode.Rn placed pump that was infusing propofol drip on standby for lab draw and forgot to restart the iv pump.It was discovered rn forgot to restart pump when patient began to have seizures an hour after infusion.Rns need to have a work around to remind them to restart pump when placed on standby.Safety concerns as prior pumps from another manufacturer had an alarm feature in their system when placed on standby.¿ additional information was received that the infusion was placed into standby at 18:37.It was an hour later when the patient began to have seizures and the issue was noted that the infusion was still in standby.The maximum standby time for the pump was not noted.Since no alarm feature on icu pump, the issue was resolved through manual restart of the pump infusion after the patient was administered medications to stop/treat the seizures.The patient was intubated in the intensive care unit (icu) and treated for sepsis, acute respiratory failure.The event did not prolong the patient¿s hospital stay.There was no other medication or solution being infused by this pump.

• 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: 10527728
• MDR Text Key: 206755174
• Report Number: 9615050-2020-00206
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 300100413
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2020
• 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: PROPOFOL, MFR UNK; UNSPEC PLUMSET, MFR ICU MEDICAL
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR