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

Model Number 550AHCT

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

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

Event Date 04/27/2023

Event Type  malfunction  

Event 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.

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.

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.

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
• Type of Device: 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
• MDR Text Key: 316035123
• Report Number: 1828100-2023-00146
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00886799001790
• UDI-Public: (01)00886799001790(11)190423
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K182110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/27/2023
• Initial Date FDA Received: 05/22/2023
• Supplement Dates Manufacturer Received: 06/02/2023; 07/21/2023
• Supplement Dates FDA Received: 06/23/2023; 07/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2019
• 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