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	10/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the manufacturer's subsidiary, the temperature value was the measured value that varied.After a while the value normalized so the device was continued to be used, and the measured values were compared to the lab data for accuracy.The variation had occurred multiple times since last summer.
Event or Problem Description
It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the blood parameter monitor (bpm) measured values were varying.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per the clinical review: on (b)(6) 2022, the team experienced a problem with the bpm during cpb whereby the temperature measure value had variation.There was no blood loss, no delay, and no change out and the procedure was completed successfully.
Additional Manufacturer Narrative
During laboratory evaluation the product surveillance technician (pst) connected the blood parameter monitor (bpm) to lab use only (luo) testing equipment and was compared against multimeter readings.At 15.0 degrees celsius (c) on the multimeter, the monitor read 14.5 c.At 34.4 c, the monitor read 36.9 c, a difference of 2.5 c.At the higher temperature, a luo bpm was also used as a comparison.The multimeter read 34.2 c and the luo bpm read 33.9 c, a difference of only 0.3 c.It was determined that the bpm was less accurate than the luo bpm.
Additional Manufacturer Narrative
Updated block: h6.The reported complaint was confirmed as there appeared to be a slight variation in the temperature reading, but the unit passed all applicable testing and 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.
Additional Manufacturer Narrative
The service repair technician (srt) could not duplicate the reported complaint.The blood parameter monitor (bpm) powered on and passed self-testing.The arterial bpm passed service mode and intensity testing.The hematocrit saturation (hsat) passed service mode testing.The erasable electronically programmable read only memory (eeprom) contained zero critical errors.The unit operated to the manufacturer's specifications.

• 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: 15813769
• Report Number: 1828100-2022-00400
• Device Sequence Number: 17493318
• 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,Followup
• Report Date (Section B): 02/24/2023

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: 11/01/2022
• Supplement Date Received by Manufacturer: 11/21/2022; 01/06/2023; 02/02/2023
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 12/12/2022; 01/27/2023; 02/24/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BLOOD GAS ANALYZER
• Patient Sex: Unknown