MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI BLOOD PARAMETER MONITORING SYSTEM 550; CARIDOPULMONARY BYPASS ON-LINE BLOOD GAS

Model Number 550AVHCT

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 05/28/2021

Event Type  malfunction  

Manufacturer Narrative

The reported complaint was confirmed.The srt noticed during oven testing that on the last cycle of four hours +/- 10% (24 minutes) at 30 degrees celsius +/- 5 degrees celsius, the venous probe failed the test with a temperature reading of 6.6 degrees celsius, which is out of specification.The srt replaced the venous probe due to intermittent thermistor readings during the oven testing and the unit operated to the manufacturer's specifications.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Event Description

The service repair technician (srt) reported that during testing of the device at the service center, the blood parameter monitor (bpm) venous probe failed the oven test with an out of specification temperature reading.There was no patient involvement.

• Brand Name: CDI BLOOD PARAMETER MONITORING SYSTEM 550
• Type of Device: CARIDOPULMONARY BYPASS ON-LINE BLOOD GAS
• 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: 12044402
• MDR Text Key: 264343191
• Report Number: 1828100-2021-00215
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00886799001783
• UDI-Public: (01)00886799001783(11)190316
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2021

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: 550AVHCT
• Device Catalogue Number: 550AVHCT
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/28/2021
• Initial Date FDA Received: 06/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2019
• 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