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

Model Number 102956

Device Problems Device Alarm System (1012); Overheating of Device (1437); Device Displays Incorrect Message (2591)

Patient Problem Hypoxia (1918)

Event Date 11/30/2020

Event Type  Injury  

Event Description

At noon last month, bivad alarmed, flow fell to 0 and alarmed "motor failure." the machine did not alarm low flow prior to this event, it just alarmed when the flow reached 0 lpm.Multiple nurses at bedside, intensivist md, respiratory therapy, and perfusionist at bedside.Map (blood pressure) dropped to 30's, patient able to speak throughout.1 albumin given, 1g cacl, 1 epi given.Cannula dressing removed, searched line for possible clots/kinks in the cannula, but none were noted.5000 units heparin given.Cannulas/pump moved to backup centrimag motor/machine with help of perfusion, nurses, respiratory, and intensivists.Blood notably separated.No alarms noted on the new machine.Previous centrimag motor hot to the touch.Patient paralyzed with mediation, given sedation and reintubated due to drop in oxygen saturation/hypoxia.The manufacturer was made aware of this event and the device was shipped back to it.

• Brand Name: CENTRIMAG MOTOR
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11045782
• MDR Text Key: 222677517
• Report Number: 11045782
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 102956
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/09/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 18615 DA
• Patient Weight: 75