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U.S. Department of Health and Human Services

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

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI BLOOD PARAMETER MONITORING SYSTEM 500; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500 Back to Search Results
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.
 
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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 Key7133551
MDR Text Key95635298
Report Number1828100-2017-00586
Device Sequence Number1
Product Code DRY
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K123039
Number of Events Reported1
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 Number500AVHCT
Device Catalogue Number500AVHCT
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/26/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/14/2017
Initial Date FDA Received12/20/2017
Supplement Dates Manufacturer Received12/19/2017
01/25/2018
04/20/2018
Supplement Dates FDA Received01/12/2018
02/19/2018
05/09/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/10/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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