MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE

Model Number 0948

Device Problem Pumping Stopped (1503)

Patient Problem Blood Loss (2597)

Event Date 10/11/2018

Event Type  malfunction  

Event Description

Pt.Was in the or.Pump head malfunctioned, placed on cardiopulm bypass.Unable to hand crank, emergently changed in 3mins.Perfusionist notified surgeon that the pump had suddenly stopped and attempts to hand crank the pump were not possible.The patient was bleeding into the pump and there was no way to pump blood back into the patient.The perfusion team immediately responded and within 3 minutes we were back on bypass after changing the pump head.Pt.Extubated prior to malfunction needed reintubation.Pt stable and back to baseline.

• Brand Name: TERUMO
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson rd; ann arbor MI 48103
• MDR Report Key: 8083993
• MDR Text Key: 127590657
• Report Number: 8083993
• Device Sequence Number: 1
• Product Code: DWB
• 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: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0948
• Device Lot Number: 0948
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/09/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20075 DA
• Patient Weight: 73