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

Model Number	550AHCT
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The service repair technician (srt) reported that during testing of the device at the service center, the blood parameter monitor (bpm) failed measured temperature accuracy testing.There was no patient involvement.
Additional Manufacturer Narrative
The reported complaint was confirmed.Per the srt, during oven testing the arterial bpm was reading 22.4 degrees celsius in a 30 degree celsius environment, which was outside of the specification range.The srt replaced the arterial bpm probe.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.

• Brand Name: CDI BLOOD PARAMETER MONITORING SYSTEM 550
• Common Device Name: 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: 14580613
• Report Number: 1828100-2022-00220
• Device Sequence Number: 11286959
• Product Code: DRY
• UDI-Device Identifier: 00886799001790
• UDI-Public: (01)00886799001790(11)190221
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K182110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/02/2022

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
• Operator of Device: Other
• Device Model Number: 550AHCT
• Device Catalogue Number: 550AHCT
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown