MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI BLOOD PARAMETER MONITORING SYSTEM 550; CARDIOPULMONARY 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	04/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the device for a non-clinical activity, the blood parameter monitor (bpm) measured value was inaccurate.There was no patient involvement.
Additional Manufacturer Narrative
Per the manufacturer's subsidiary, the temperature in the room was around 20 degrees and the bpm temperature measurement value went higher and higher up to 40 degrees.The controlled temperature in the pseudo blood circuit was around 23 degrees while the measure temperature on the standard thermometer displayed 22.9 degrees and the bpm measured 30.8 degrees.The temperature was tested in the same condition and the value changed a few times before stabilizing.
Additional Manufacturer Narrative
During laboratory analysis, the product surveillance technician (pst) connected the blood parameter monitor (bpm) to lab use only (luo) testing equipment.The monitor was powered up and the erasable electronically programmable read only memory (eeprom) showed no critical errors.The pst observed the arterial bpm probe to fail temperature check during service mode testing as it issued an 'arterial temperature out of range' message.It was determined that the bpm did not meet specification.
Additional Manufacturer Narrative
The reported complaint was confirmed.The service repair technician (srt) observed the arterial blood parameter monitor (bpm) probe to fail the temperature check during service mode testing.The arterial bpm probe passed intensity testing.The srt replaced the arterial bpm probe due to intermittent temperature failures.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: CARDIOPULMONARY 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: 16974113
• Report Number: 1828100-2023-00146
• Device Sequence Number: 20457920
• Product Code: DRY
• UDI-Device Identifier: 00886799001790
• UDI-Public: (01)00886799001790(11)190423
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/26/2023

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
• Operator of Device: Health Professional
• Device Model Number: 550AHCT
• Device Catalogue Number: 550AHCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2023
• Supplement Date Received by Manufacturer: 06/02/2023; 07/21/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 06/23/2023; 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2019
• 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