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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) verified the reported complaint.He replaced the printed circuit board (pcb), the motor cable, and the pump display.The unit operated to the manufacturer's specifications.

Event Description

It was reported that the unit did not show any flow.As a result, an alternate device was employed.There was no blood loss, nor adverse consequences to the patient.No other details regarding the nature of this event were provided.

Manufacturer Narrative

Corrected block: d9.

Manufacturer Narrative

Updated block: h6 the reported complaint was confirmed.During the laboratory analysis, the product surveillance technician (pst) observed the customer components to function as intended.The pst disassembled the the lab use only (luo) control module and installed the customer printed circuit (pc) assembly, pump display assembly membrane and motor cable assembly.Testing was completed multiple times successfully and the flow reading was visible.It was determined that the pc assembly, pump display assembly membrane and the motor cable assembly all functioned as intended.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: 12795860
• MDR Text Key: 281683195
• Report Number: 1828100-2021-00417
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/18/2022

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: Health Professional
• Device Model Number: 6379
• Device Catalogue Number: 6379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 11/11/2021
• Supplement Dates Manufacturer Received: 12/02/2021; 02/18/2022
• Supplement Dates FDA Received: 12/02/2021; 02/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2003
• 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