MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI BLOOD PARAMETER MONITORING SYSTEM 500; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500

Model Number 500AVHCT

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

Patient Problem No Patient Involvement (2645)

Event Date 08/27/2020

Event Type  malfunction  

Manufacturer Narrative

Per the srt, the test chamber cycles between 20c (celsius) +/- 5c to 30c +/- 5c for 24 hours and the arterial temperature readings (12.1c; 14.8c; 14.9c) were below specifications.

Event Description

The service repair technician (srt) reported that during testing of the device at the service center, the arterial blood parameter monitor (bpm) failed chamber test and displayed erratic temperature readings.There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) installed the arterial probe in a lab-use only (luo) monitor and a traveling standard reference sensor test (srs) was attached for testing purposes.The printer was turned on and set to capture every five minutes to mimic the bemco parameters and to capture the temperature data generated by the bpm probe.The probe was put into the refrigerator for 30 minutes dropping the temperature to 10.5 celsius.Once removed to the fridge and allowed to be brought back to room temperature the data collected showed a gradual trend down and back up to room temperature.While the probe was at room temperature the cable was stressed and this action resulted in a f101 error code being logged, suggesting an internal electrical issue.The service repair technician replaced the arterial probe.The unit operated to 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 500
• Type of Device: MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 10563006
• MDR Text Key: 207820373
• Report Number: 1828100-2020-00364
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• PMA/PMN Number: K133658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 500AVHCT
• Device Catalogue Number: 500AVHCT
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1