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

Model Number 500AHCT

Device Problems Thermal Decomposition of Device (1071); Electrical Shorting (2926)

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

Event Date 04/24/2014

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure, the blood parameter monitor (bpm) alarmed and turned off on its own during case and would not turn back on.The perfusionist (ccp) did not know how much longer the case would be, so he changed out the bpm.The case ended fifteen minutes later.The surgical procedure was completed successfully.There were no delays, no blood loss, or no adverse consequences to the patient.Per the clinical review on (b)(6) 2014: the bpm "shut down" during the procedure and there were no values being displayed to the user.A back-up bpm was used for the remainder of the procedure.There were no issues with the accuracy of the bpm information, only total loss of the monitor was reported.No delay in the procedure and the case was completed successfully without associated blood loss.

Manufacturer Narrative

The reported complaint was confirmed by service technician.Per the laboratory evaluation, the technician observed that the loss of power was due to a burnt capacitor on the aux printed circuit board assembly (pcba).The product will be 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: 3928585
• MDR Text Key: 4535450
• Report Number: 1828100-2014-00528
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/07/2014

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: Health Professional
• Device Model Number: 500AHCT
• Device Catalogue Number: 500AHCT
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/06/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2014
• Initial Date FDA Received: 06/09/2014
• 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