MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEM CORP TERUMO CDI 100 MONITOR

Model Number 100

Device Problems Fluid/Blood Leak (1250); Battery Problem (2885)

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

Event Date 08/13/2013

Event Type  malfunction  

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the monitor display blanked out intermittently.As a result, an alternate device was employed.The surgical procedure was completed successfully, and there were no delays, no blood loss or no adverse consequences to the pt.

Manufacturer Narrative

This complaint was confirmed.During the investigator's review on (b)(4) 2014, a cracked battery was found inside the unit.Battery fluid had leaked out of the battery into the unit, damaging the circuits and also present on the circuit board.Battery acid is conductive and can create short circuit conditions and is considered to have caused the system shut down seen by the customer.The unit has been forwarded to the service department for disposition.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 100 MONITOR
• Type of Device: CDI 100
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEM CORP; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 3744358
• MDR Text Key: 18361647
• Report Number: 1828100-2014-00053
• 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: 01/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2014
• 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: 01/22/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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