MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO CDI 500 BLOOD PARAMETER MONITOR

Model Number 500AHCT

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 12/21/2014

Event Type  malfunction  

Event Description

It was reported that during the use of the device for a non-clinical activity, the blood parameter monitor (bpm) would not stay on when unplugged.Issue found when the unit was being moved over the weekend.There was no patient involvement.

Manufacturer Narrative

The reported issue was confirmed during laboratory evaluation.After eight plus hours of charging, the monitor was turned on with alternating current (a/c) power supplied and then removed.The monitor shut off immediately.The 12v battery is defective and was found to have leaked fluid and has cracks in the case where it leaked.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 500 BLOOD PARAMETER MONITOR
• Type of Device: CDI 500
• 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: 4762760
• MDR Text Key: 5792762
• Report Number: 1828100-2015-00414
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 500AHCT
• Device Catalogue Number: 500AHCT
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/13/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2005
• 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