MAUDE Adverse Event Report: ABBOTT LABORATORIES CENTRIMAG; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Device Problems Device Alarm System (1012); Battery Problem (2885)

Patient Problems Low Blood Pressure/ Hypotension (1914); Asystole (4442)

Event Date 10/05/2020

Event Type  malfunction  

Event Description

Ecmo monitor alarmed showing b1 battery failure.Perfusion was at the bedside at this time.She put on a gown and went into the room.Alarm was silenced.It cleared and reset, but decision was made to switch patient to backup pump.During time of pump exchange, patient had 18 seconds of asystole with no blood pressure.Critical care attending at the bedside with epinephrine but was not needed as when the new pump was returned to speed, the patient recovered.

• Brand Name: CENTRIMAG
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park rd.; abbott park IL 60064
• MDR Report Key: 10808686
• MDR Text Key: 215314825
• Report Number: 10808686
• Device Sequence Number: 1
• Product Code: DWA
• 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: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/06/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25185 DA