MAUDE Adverse Event Report: RAPID INFUSER; PUMP, INFUSION

Device Problems Failure to Prime (1492); Visual Prompts will not Clear (2281); Key or Button Unresponsive/not Working (4063)

Patient Problem Ruptured Aneurysm (4436)

Event Date 09/21/2020

Event Type  Death  

Event Description

Last night i was called for a ruptured abdominal aortic aneurysm (aaa).Once i arrived, i got a cell saver in the room set up and ready.I went to the inner core of the or, powered on the rapid infusion system (ris) unit and set up the rapid infuser system disposables.Once set up, i began to prime the circuit and the patient delivery line, which was quick and uneventful.Once that was complete i took the ris into room 2 and plugged it into an outlet near the cell saver.At that point, i was getting ready to connect to anesthesia.I wanted to purge air at the tip of the patient line before connection.None of the buttons on the device were functioning.Neither the prime, infusion options (bolus, rate, etc), recirculation or start button were functioning.I shut the circuit down and rebooted.The screen booted up appropriately, however the screen again was frozen, including the prime button.I removed all disposables, turned the circuit off and procured new disposables.I powered the system up, changed to a new disposable set and pressed prime.The screen remained frozen and would not prime.During this time, one of the crna's on the procedure also looked at the device and was unable to get it to operate.At the same time, the or called the er for their ris.Once it arrived, i powered the system up, set up the disposables and pressed prime.Once the circuit was primed, i primed the patient delivery line free of air, connected to the patient and began delivering fluid to the patient.

• Brand Name: RAPID INFUSER
• Type of Device: PUMP, INFUSION
• MDR Report Key: 11228903
• MDR Text Key: 228634381
• Report Number: 11228903
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/22/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 30660 DA