MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY ROTOFLOW DRIVE; ECMO PUMP

Model Number 70102.2161

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Death (1802); Intracranial Hemorrhage (1891)

Event Date 01/06/2017

Event Type  Death  

Event Description

Per ecmo specialist: rotoflow suddenly alarms.'error' and it is noted that pt flows are decreasing rapidly with correlating drop in pt mbp to 30's.Staff assist hit, pt clamped out and rotoflow head switched into handcrank.Pt unclamped and flows obtained with handcrank.Physician at bedside.Pt given one code dose or epinephrine.Perfusionist notified.Pt taken to emergency ventilator settings.Pt otherwise maintaining blood pressures.Pt continued to be handcranked while pump turned on and off without resolution of alarm.Full rotoflow pump and head taken off pump and replaced with new rotoflow head and pump.Pt clamped out again and switched to a new pump.Pt unclamped and flows achieved at baseline (approx 5l).Perfusionist at bedside.Pt flow taken down to 4.4 lpm, rpm at 3115.Pt tolerating well.A change in pupils response noted later in the morning at approx 09:50 am.Scans obtained showed extensive intracranial hemorrhages with generalized loss of gray-white differentiation.Pt passed away later in the day at 13:08 pm.

• Brand Name: ROTOFLOW DRIVE
• Type of Device: ECMO PUMP
• Manufacturer (Section D): MAQUET CARDIOPULMONARY; kehler str. 31; rastatt ; GM
• MDR Report Key: 6255674
• MDR Text Key: 64918465
• Report Number: 6255674
• Device Sequence Number: 1
• Product Code: KFM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/10/2017,01/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70102.2161
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/10/2017
• Distributor Facility Aware Date: 01/06/2017
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening; Required Intervention
• Patient Age: 13 YR
• Patient Weight: 32