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

Model Number 100

Device Problems Leak/Splash (1354); Battery Problem (2885)

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

Event Date 01/01/2013

Event Type  malfunction  

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the hematocrit (hct)/ oxygen (o2) saturation monitoring display would go out after less than five minutes.The user would turn the unit off and plug it in, but it would still only run for less than five minutes.The device was not changed out, as the unit was not used for case.The surgical procedure was completed successfully, and there were no delays, no blood loss or no adverse consequences to the pt.

Manufacturer Narrative

This has been going on for a while.Exact dates were not documented by the customer.Upon receipt of the unit, it was noted that a cracked battery was in the unit and caused an intermittent failure due to battery acid leaking into the unit.This issue makes this complaint now reportable.A cracked battery was found that had leaked internal fluid.The battery leaking was confirmed to have reached the printed circuit board assembly (pcba).Battery acid has damaged the circuits and was present on the circuit board (acid is conductive and can create short circuit conditions) and is considered to have caused the blanking out issue.If additional info 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 SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 3747718
• MDR Text Key: 4549237
• Report Number: 1828100-2014-00041
• 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: 01/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2014
• 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: 01/16/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2014
• 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