MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS CENTRIFUGAL PUMP WITH X-COATING; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 164275X

Device Problems Leak/Splash (1354); Overheating of Device (1437)

Patient Problem Insufficient Information (4580)

Event Date 02/03/2022

Event Type  malfunction  

Event Description

Cardiopulmonary bypass (cpb) machine stopped working mid-case.Surgeon was implanting tricuspid valve and patient was on cpb.Cpb pump suddenly stopped spinning.Perfusion, hand cranked cpb machine.Additional perfusion called into help.Chest compressions were initiated when cpb stopped pumping.Console gave a ¿reverse flow¿ alarm and some pressure alarm.Motor stopped spinning.Head moved to hand crank and cranked ok.Motor unit was extremely hot.Too hot to hold hand on.Perfusion later test ran the same pump and motor for several hours with no issues.Pump later tested by clinical engineering and unable to duplicate problem.Some moisture was visible on the bearing side of the pump head, indicating some leakage of the seal, but was still spinning freely.Manufacturer response for heart-lung bypass pump, terumo (per site reporter) pending evaluation.

• Brand Name: SARNS CENTRIFUGAL PUMP WITH X-COATING
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 13618607
• MDR Text Key: 286234320
• Report Number: 13618607
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 164275X
• Device Catalogue Number: 164275X
• Device Lot Number: ZL23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/16/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27740 DA
• Patient Sex: Male