MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO CDI 101 MONITOR; CDI 101 (7101) INTERFACE MODEL

Model Number 101

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2014

Event Type  malfunction  

Event Description

It was reported that during use of the device for a procedure, there was an important deviation of blood parameters: hemoglobin (hgb) and hematocrit (hct).The device was not changed out.The surgical procedure was completed successful.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

The reported complaint is not verifiable.This device is no longer marketed in the united states.This event occurred in (b)(4).This device will not be returned to the manufacturer.The product can not be analyzed to determine failure mode.

• Brand Name: TERUMO CDI 101 MONITOR
• Type of Device: CDI 101 (7101) INTERFACE MODEL
• 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: 4189366
• MDR Text Key: 5101916
• Report Number: 1828100-2014-00878
• Device Sequence Number: 1
• Product Code: DTY
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101
• Device Catalogue Number: 101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1828100-10/27/11-024-R
• Patient Sequence Number: 1