MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Device Problem Mechanical Problem (1384)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 12/23/2018

Event Type  Injury  

Event Description

Centrimag unable to achieve set speed.Speed set for 4400.Console alarmed one time stating that set speed wasn't achieved.Speed on display was 3300 and flows showed "---".Motor was hot to touch.Patient was hypotensive.Critical care md and mcs rn at bedside to urgently switch motors.Patient became severely hypotensive during pump switch.Speed of 4400 achieved and flows regained after pump was successfully switched.

• Brand Name: CENTRIMAG BLOOD PUMP
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; 6035 stoneridge dr; pleasanton CA 94588
• MDR Report Key: 8284792
• MDR Text Key: 134330890
• Report Number: 8284792
• Device Sequence Number: 1
• Product Code: KFM
• 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: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: Yes
• 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: 12/26/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 7300 DA