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 Measurement (1383)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

As per perfusionist, the hemoglobin (hgb) reading was not accurate as before, it would drift, and readings higher than 12.5 cannot be recorded.A continuous re-calibration of venous oxygen saturation (b)(4) has been encountered.

Event Description

It was reported that the device was more inaccurate than they were before the upgrade.No other details regarding the nature of this event were provided.

Manufacturer Narrative

Per the manufacturer's subsidiary, the user facility was incorrectly entering hemoglobin (hb) values to stop the alarm from sounding.This was causing the other values to be incorrect.This was done due to the increased alarm limits and the fact that the alarm cannot be turned off.

Manufacturer Narrative

The reported complaint was confirmed.Multiple diligence attempts for part return and additional information were unsuccessful.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: 7789011
• MDR Text Key: 117295753
• Report Number: 1828100-2018-00427
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2018

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: 500AHCT
• Device Catalogue Number: 500AHCT
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/23/2018
• Initial Date FDA Received: 08/16/2018
• Supplement Dates Manufacturer Received: 08/22/2018; 10/26/2018
• Supplement Dates FDA Received: 09/14/2018; 11/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1828100-08/07/15-002-C
• Patient Sequence Number: 1