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 Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure (cpb), the hematocrit saturation module (h/sat) was reading inaccurately.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: the certified clinical perfusionist (ccp) has seen 3 times, with the most recent occurrence being (b)(6) 2017, error messages that he either resolves or that resolve itself.(he cannot recall the error messages) due to the concern that the unit is giving errors, he had concerns about the true accuracy of the values being displayed during the procedure.This incident occurred on bypass and the ccp opted to not change out the unit.According to the cpp the unit passed calibration, and in-vivo calibration was performed with values stored in the unit.The surgical procedure was completed successfully, and there was no harm nor blood loss to the patient.

Manufacturer Narrative

During laboratory analysis, product surveillance technician (pst) observed that there were no issue with core monitor functions.The monitor completed the boot process without any failures or error codes.The system successfully performed a sample calibration and it demonstrated consistent intensity values over a duration of several hours.

Manufacturer Narrative

The service repair technician (srt) replaced the hematocrit saturation module (h/sat) sensor.The monitor successfully passed startup self-diagnostic test with no errors.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 Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 6973872
• MDR Text Key: 90857463
• Report Number: 1828100-2017-00487
• 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: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• 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
• Other Device ID Number: GTIN: (01)00886799001622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2001
• 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