MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEM 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 No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation is in progress, but not yet concluded.

Event Description

It was reported that the device was reporting wrong arterial numbers.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no blood loss nor adverse consequences to the patient.Diligence attempts were made for the remaining surgery related questions but were unsuccessful.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) evaluated the blood parameter monitor (bpm) for accuracy.No specific information was communicated by the customer as to which arterial value or values were incorrect.Reference and data intensity values were acceptable and stable, gas calibrations were successfully performed, and in-vivo adjustments demonstrated the ability to fine-tune onscreen information.The temperature reported by the bpm differs from another bpm by approximately one degree celsius (c) at 15 and at 35 degrees c.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

The complaint was confirmed.The difference in temperature noted in the laboratory analysis is larger than is typical based on temperature accuracy data indicated in operator¿s manual, which indicates a mean temperature difference of -0.07 degrees and a standard deviation of 0.22 based on in-house sampling of blood paramater (bpm) monitors.This would result in inaccurate values for the other bpm parameters, given the relationship of temperature into the algorithms.Per the manufacturer's central engineering, the hematocrit saturation module (h/sat) cannot be tested on the blood loop due to a broken h/sat clip.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.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 SYSTEM CORPORATION; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: katie hoyt ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 6681206
• MDR Text Key: 79031092
• Report Number: 1828100-2017-00291
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/07/2017
• Initial Date FDA Received: 06/30/2017
• Supplement Dates Manufacturer Received: 08/04/2017; 10/05/2017
• Supplement Dates FDA Received: 08/28/2017; 10/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2001
• 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