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 04/20/2015

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) would spike to 100% and the hemoglobin (hgb) would drop up and down then alarm on the blood parameter monitor (bpm).The device was not changed out, as they turned off the bpm since the unit kept alarming.Laboratory analysis was performed for the remainder of the procedure.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the pt.Per the clinical review on 05/07/2015: the had issues with failing the color chip test during start-up of the monitor and later during cpb, the svo2 would spike to 100% and the hgb was rapidly changing, though no clinical conditions were changing.In the end, as the bpm kept alarming, they shut off the bpm for the remainder of the procedure and used a laboratory analyzer for venous samples.In review of these complaints and they had issue with color chip test, they may have had an issue with coupling of the hematocrit saturation module (h/sat) probe to the color chip and the cuvette of the circuit.They may have held the h/sat probe against the side of the monitor during boot-up and then had coupling issues of h/sat probe with cuvette during cpb and this could explain the svo2 and hgb issues during cpb.The case was completed successfully, with no delay and no associated blood loss and no harm was observed.

Manufacturer Narrative

This complaint is related to mdr # 1828100-2015-00435.

Manufacturer Narrative

(b)(4).The reported complaint was confirmed.The customer observed color chip failures during setup and continued to use the monitor anyway, then observed hematocrit saturation module (h/sat) inaccuracies for oxygen saturation (so2) and hemoglobin (hgb) during surgery.Per the blood parameter monitor (bpm) operator's manual, the user should not continue to use the h/sat probe if color chip errors are persistent.During laboratory evaluation, the fluctuating h/sat values were duplicated while manipulating the h/sat cable near the strain relief, indicating a defective cable.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: 4777983
• MDR Text Key: 5853263
• Report Number: 1828100-2015-00434
• 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
• Type of Report: Initial
• Report Date: 09/02/2015

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2015
• Initial Date FDA Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2001
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1828100-08/09/2010-004-C
• Patient Sequence Number: 1