MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS CENTRIFUGAL SYSTEM; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS-SARNS CENTRIFUGAL SYSTEM

Model Number 6382

Device Problem Device Alarm System (1012)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) found that during testing of the flow sensor a flow reading was present while the tubing was not connected.The fsr replaced the flow sensor probe and ran release testing successfully.The unit operated to the manufacturer's specifications.

Event Description

It was reported that the flow sensor was giving a backflow alarm.No other details regarding the nature of this event were provided.

Manufacturer Narrative

The reported complaint was confirmed.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

Updated blocks: d1, d2, d9 and g4.During laboratory analysis.The product surveillance technician (pst) observed, the flow sensor to run for three hours and 15 minutes with no backflow alarm.The flow sensor passed verification/release testing.

• Brand Name: SARNS CENTRIFUGAL SYSTEM
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS-SARNS CENTRIFUGAL SYSTEM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 12327952
• MDR Text Key: 268148433
• Report Number: 1828100-2021-00283
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K950739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6382
• Device Catalogue Number: 6382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1