MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI BLOOD PARAMETER MONITORING SYSTEM 500; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500

Model Number 500AVHCT

Device Problems Thermal Decomposition of Device (1071); Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per the manufacturer's subsidiary, the side of the printer had high heat and smelled as if the motor was burnt.The user facility continued to use the device without the printer.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, there was smoke and a burnt odor.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

The reported complaint could not be confirmed.The service repair technician (srt) was not able to duplicate the reported issue.The srt installed a new printer.The unit operated to the manufacturer's specification.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed the printer to work as intended.There was no obvious or apparent ¿burnt¿ smell from the printer, printer wires not charred, no evidence that motor got extremely hot, no dis-colorization of the motor itself or of its wires due to excessive heat.

Event Description

Per clinical review: during a cardiopulmonary bypass (cpb) procedure, the clinical engineers/perfusionists saw smoke generation and a burnt odor near the location of the printer on the blood parameter monitor (bpm).The clinicians noted that it was very little smoke and that the area near the printer on the monitor was hot to the touch.They did not changed out the monitor, they continued the case without the use of the printer.The printer is an ancillary part that if the printer fails, the unit can function fully without any concern.The incident did not delay the surgical procedure.There was no harm to either the patient or the clinician due to the generation of a small amount of smoke.There was no blood loss associated with the event.

Manufacturer Narrative

During additional laboratory analysis, the product surveillance technician (pst) tested the power supply and it worked as intended.No damaged components or burning was noted.

• Brand Name: CDI BLOOD PARAMETER MONITORING SYSTEM 500
• Type of Device: MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 7133551
• MDR Text Key: 95635298
• Report Number: 1828100-2017-00586
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/09/2018

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: 500AVHCT
• Device Catalogue Number: 500AVHCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 12/20/2017
• Supplement Dates Manufacturer Received: 12/19/2017; 01/25/2018; 04/20/2018
• Supplement Dates FDA Received: 01/12/2018; 02/19/2018; 05/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2009
• 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