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

Model Number 6379

Device Problem Unable to Obtain Readings (1516)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/17/2022

Event Type  malfunction  

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) connected the control module to lab use only (luo) testing equipment.Once the module was powered on and set to 1290 revolutions per minute (rpm) the control module failed with no flow reading.After opening the control module, he observed that the power connector to the flow meter board was flipped upside down.After reseating the connection in the correct orientation, the reading then showed, and the device operated normally.

Event Description

It was reported that during incoming inspection of the device at the service center, the centrifugal system had a note on it that the flow was not reading.There were no reported adverse consequences to the patient.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.

• 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
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 15779677
• MDR Text Key: 304080412
• Report Number: 1828100-2022-00385
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 6379
• Device Catalogue Number: 6379
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/17/2022
• Initial Date FDA Received: 11/11/2022
• Supplement Dates Manufacturer Received: 01/03/2023
• Supplement Dates FDA Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/1996
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1