TERUMO PERFUSION SYSTEM 8000 5773

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-07-07 for TERUMO PERFUSION SYSTEM 8000 5773 manufactured by Terumo Cardiovascular Systems Corp..

Event Text Entries

[1409565] During prime in preparation for use of the device for a cardiopulmonary bypass procedure, the user reported the air bubble detector alarm occurred continuously. An alternate device was employed for the procedure. No other details regarding the event were provided. There were no reported adverse consequences to a patient as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


[8637469] Evaluation in progress, but not yet concluded.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1828100-2010-00772
MDR Report Key1750363
Report Source05,06
Date Received2010-07-07
Date of Report2010-07-07
Date of Event2010-06-17
Date Mfgr Received2010-06-17
Date Added to Maude2010-08-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactSTEVEN ARICK
Manufacturer Street6200 JACKSON RD.
Manufacturer CityANN ARBOR MI 48103
Manufacturer CountryUS
Manufacturer Postal48103
Manufacturer Phone7347416238
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTERUMO PERFUSION SYSTEM 8000
Generic NameAIR BUBBLE DETECTOR
Product CodeKRL
Date Received2010-07-07
Returned To Mfg2010-06-28
Model Number5773
Catalog Number5773
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerTERUMO CARDIOVASCULAR SYSTEMS CORP.
Manufacturer AddressANN ARBOR MI 48103 US 48103


Patients

Patient NumberTreatmentOutcomeDate
10 2010-07-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.