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

Model Number 500AHCT

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Date 11/01/2014

Event Type  malfunction  

Event Description

The service repair technician (srt) reported that during routine testing of the device at the service center, there was a burn smell coming from blood parameter monitor (bpm).There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.The product surveillance technician (pst) inspected the bpm, a strong odor of something or component got extremely hot and a burn smell was present inside the bpm.Inspection of the bpm's internal single board computer (sbc) printed circuit board assembly (pcba) component u16, shows evidence of extreme heat generation as the top of the integrated circuit (i/c) is discolored.The product was sent to service to be brought to manufacturers specifications before being returned to the customer.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: 4290895
• MDR Text Key: 5052092
• Report Number: 1828100-2014-01000
• 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: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 500AHCT
• Device Catalogue Number: 500AHCT
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/22/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/01/2014
• Initial Date FDA Received: 11/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2012
• 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