MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO CDI 100 MONITOR

Model Number 100

Device Problems Break (1069); Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure, the blood parameter monitor (bpm) was not accurate.This issue has occurred a couple of times and exact dates are unk by customer.The device was not changed out, as the customer used a lab analyzer to finish the case.The surgical procedure was completed successfully.There were no delays, no blood loss, or no adverse consequences to the pt.Per the clinical review on (b)(6) 2014: after consultation with the clinical team, it was discovered that the clip on the h/sat probe was broken and the security of the probe to the cuvette was not ideal.This would at times lead to inaccurate data (both hematocrit and saturation).This was found by the perfusionist and the data was not used to clinically manage the pt.Add'l lab samples were taken to better monitor and manage these values.The case was completed successfully, without delay and without associated blood loss.

Manufacturer Narrative

Eval is in progress, but not yet concluded.

• Brand Name: TERUMO CDI 100 MONITOR
• Type of Device: CDI 100
• 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: 3966259
• MDR Text Key: 16988207
• Report Number: 1828100-2014-00542
• Device Sequence Number: 1
• Product Code: DTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K902654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100
• Device Catalogue Number: 100
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/17/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2014
• Was Device Evaluated by Manufacturer?: No
• 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