MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO CDI 500 BLOOD PARAMETER MONITOR

Model Number 500AHCT

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/22/2015

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the saturated venous oxygen (svo2) reading was not accurate on the blood parameter monitor (bpm).This issue has occurred since the recent notice of field correction (nfc) upgrade.The device was not changed out, as they continued to use.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per the clinical review on 04/24/2015: this behavior was observed after the bpm unit had been upgraded from version 1.65 to 1.69.The unit passed the color chip test at monitor start-up.In the first minutes of cpb, the svo2 was significantly lower than what they usually saw with version 1.65.The svo2 was being measured between 50-60%, even though the blood color in the venous line appeared brighter than this measured level.When an in-vivo calibration was performed 10-15 minutes into pcb, it was observed the svo2 measure of the bpm was 10-20% points lower than the laboratory analyzer.After the svo2 of the bpm was adjusted to the laboratory analyzed value, the bpm was closer the remainder of the procedure, usually less than or equal to 5% points of the laboratory analyzed value.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.

Manufacturer Narrative

This complaint is related to mdr #1828100-2015-00397 and mdr #1828100-2015-00399.Evaluation is in progress, but not yet concluded.During laboratory evaluation, the monitor passed start-up self diagnostics with no errors observed.The monitor was placed in its service mode and hematocrit saturation module (h/sat) color chip and cuvette tests were performed, both passed.The monitor will be sent to central engineering for further testing.

Manufacturer Narrative

The reported complaint was not verifiable.During testing in central engineering, a separate issue was identified that did not allow for further testing and the reported customer issue could not be duplicated.The hematocrit (hct) and hemoglobin (hgb) values would not display and the oxygen saturation (so2) value would be stuck at 100, and the monitor would not accept an in-vivo calibration.Further investigation found this was due to a single board computer (sbc) hardware failure which was investigated under another complaint.The product will be sent to service to be brought to manufacturers specifications before being returned to the customer.No additional action will be taken at this time.

• Brand Name: TERUMO CDI 500 BLOOD PARAMETER MONITOR
• Type of Device: CDI 500
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4777967
• MDR Text Key: 5779698
• Report Number: 1828100-2015-00398
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/05/2015

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
• Date Returned to Manufacturer: 05/04/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2015
• Initial Date FDA Received: 05/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1828100-08/07/15-002-C
• Patient Sequence Number: 1