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 500AHCT

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

Patient Problem Insufficient Information (4580)

Event Date 04/09/2021

Event Type  malfunction  

Event Description

It was reported that the gas reading on the blood parameter monitor (bpm) was inaccurate.No other details regarding the nature of the event were provided.

Manufacturer Narrative

The reported complaint is not verifiable.Multiple diligence attempts for part return were unsuccessful so an evaluation could not be completed.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed the blood parameter monitor (bpm) setting indicated 'factory default' calibration values were in use.Several calibrations were indicated in the erasable electronically programmable read only memory (eeprom) which occurred after the date of the complaint.If the default calibration setting is set to 'factory default', gas calibrations have no effect in the calibration of the values displayed on the screen.With the user settings left as-received, on screen values were all adjusted to sample values using 'store/recall'.The flow rate was set manually.The hematocrit saturation (hsat) was clipped to a 3/8 inch cuvette.All of the values displayed were displayed on the screen and could be fine tuned using the 'store/recall' function.The monitor default calibration was set to the last calibration values.After cycling the power, the monitor was connected to the lab use only (luo) bpm calibrator.The sample gas calibration was successful.In operate mode, all on-screen values could be adjusted using 'store/recall', as before.

Manufacturer Narrative

The reported complaint was confirmed.The service repair technician (srt) replaced the hematocrit saturation probe due to damage on the 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 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
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 11772779
• MDR Text Key: 251380820
• Report Number: 1828100-2021-00158
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 500AHCT
• Device Catalogue Number: 500AHCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2009
• 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