SARNS 8000 MODULE PERFUSION SYSTEM 149673

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-27 for SARNS 8000 MODULE PERFUSION SYSTEM 149673 manufactured by Terumo Cardiovascular Systems Corporation.

Event Text Entries

[91354271] (b)(4). As per the field service representative (fsr), the abd was cleaned and the connection to the safety monitor was tightened. The unit operated to the manufacturer's specifications. If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
Patient Sequence No: 1, Text Type: N, H10


[91354272] It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the air bubble detector (abd) kept alarming. The surgical procedure was completed successfully. There was no delay, no blood loss, nor adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1828100-2017-00491
MDR Report Key6984175
Date Received2017-10-27
Date of Report2017-10-27
Date Mfgr Received2017-10-02
Date Added to Maude2017-10-27
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 FDA3
Event Location3
Manufacturer ContactMS. KATIE HOYT
Manufacturer Street6200 JACKSON ROAD
Manufacturer CityANN ARBOR MI 48103
Manufacturer CountryUS
Manufacturer Postal48103
Manufacturer Phone7346634145
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSARNS 8000 MODULE PERFUSION SYSTEM
Generic NameDETECTOR, BUBBLE, CARDIOPULMONARY BYPASS-SARNS 8000 PERFUSION SYSTEM
Product CodeKRL
Date Received2017-10-27
Model Number149673
Catalog Number149673
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTERUMO CARDIOVASCULAR SYSTEMS CORPORATION
Manufacturer Address6200 JACKSON ROAD ANN ARBOR MI 48103 US 48103


Patients

Patient NumberTreatmentOutcomeDate
10 2017-10-27

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