MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH/ ABBOTT LABORATORIES CENTRIMAG PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Lot Number L01954-0009

Device Problem No Flow (2991)

Patient Problems Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477)

Event Date 03/10/2021

Event Type  malfunction  

Event Description

While moving centrimag motor/console from ecmo cart to patient stretcher to transport an ecmo patient to ct scan, the flow and rpms went to zero.The perfusionist doing the transport immediately attempted to go up/down on rpm's with no change occurring.She then clamped the circuit and switched the head over to the backup, restoring ecmo flows.During this brief period the patient desaturated and became hypotensive, epi was pushed and respiratory was actively ventilating.No chest compressions were done, patient did not go asystole.Fda safety report id # (b)(4).

• Brand Name: CENTRIMAG PRIMARY CONSOLE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH/ ABBOTT LABORATORIES
• MDR Report Key: 11541460
• MDR Text Key: 241815222
• Report Number: MW5100150
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/18/2021

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: No Information
• Device Lot Number: L01954-0009
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR