SARNS 8000 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 2016-08-05 for SARNS 8000 PERFUSION SYSTEM 149673 manufactured by Terumo Cardiovascular Systems Corp..

Event Text Entries

[51372447] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[51372448] It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the red ultrasonic air sensor (uas) latch was broken. As a result, an alternate device was employed. 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


[55357240] The reported complaint was confirmed. Per user facility biomedical engineer (biomed), the repair to the red ultrasonic air sensor (uas) was completed. No part will be returned to the manufacturer for evaluation. 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


MAUDE Entry Details

Report Number1828100-2016-00538
MDR Report Key5849810
Date Received2016-08-05
Date of Report2016-09-09
Date of Event2016-07-14
Date Mfgr Received2016-09-09
Date Added to Maude2016-08-05
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 FDA3
Event Location3
Manufacturer ContactMS. JAN WINDER
Manufacturer Street6200 JACKSON ROAD
Manufacturer CityANN ARBOR MI 48103
Manufacturer CountryUS
Manufacturer Postal48103
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSARNS 8000 PERFUSION SYSTEM
Generic NameDETECTOR, BUBBLE, CARDIOPULMONARY BYPASS-SARNS 8000
Product CodeKRL
Date Received2016-08-05
Model Number149673
Catalog Number149673
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTERUMO CARDIOVASCULAR SYSTEMS CORP.
Manufacturer Address6200 JACKSON ROAD ANN ARBOR MI 48103 US 48103


Patients

Patient NumberTreatmentOutcomeDate
10 2016-08-05

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