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 Patient Involvement (2645)

Event Date 09/09/2014

Event Type  malfunction  

Event Description

It was reported that during set-up of the device for a procedure, there were drifting hematocrit (hct) values.There was no patient involvement.No other details regarding the nature of this event were provided.

Manufacturer Narrative

The reported complaint was not verifiable.This device is no longer marketed in the united states.This event occurred in (b)(6).The device will not be returned to the manufacturer for further evaluation and can not be analyzed to determine the failure mode.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: 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 ; 7366634145
• MDR Report Key: 4196947
• MDR Text Key: 4980967
• Report Number: 1828100-2014-00870
• Device Sequence Number: 1
• Product Code: DTY
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K920654
• 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: 09/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2014
• 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: 09/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2006
• 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