MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SHUNT SENSOR SYS500 BLOOD GAS MONITOR

Model Number CDI510H

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/10/2021

Event Type  malfunction  

Manufacturer Narrative

Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed. Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available. (b)(4).

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, a leakage was observed near the female connector. No known impact or consequence to patient. Product was changed out. Procedure was completed successfully.

• Brand Name: SHUNT SENSOR SYS500
• Type of Device: BLOOD GAS MONITOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer (Section G): SAME
• Manufacturer Contact: jamie quinlan ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 12546046
• MDR Text Key: 273777434
• Report Number: 1124841-2021-00224
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/30/2022
• Device Model Number: CDI510H
• Device Catalogue Number: N/A
• Device Lot Number: ZF03F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 11/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial