SARNS 8000 PERFUSION SYSTEM 5773

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-26 for SARNS 8000 PERFUSION SYSTEM 5773 manufactured by Terumo Cardiovascular Systems Corp..

Event Text Entries

[39484757] (b)(4). The uabd latch is on backorder, the fsr will return to the user facility when the latch is available. Pm inspections are complete and the unit operated to manufacturer specifications and was returned to clinical use.
Patient Sequence No: 1, Text Type: N, H10


[39484758] The field service representative (fsr) reported that during preventive maintenance (pm) of the device, the ultrasonic air bubble detector (uabd) latch was broken into two pieces. The fsr found the latch was taped together. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5


[44790522] The field service representative (fsr) returned to the user facility to replace backordered air bubble detector (abd) draw latch and checked operation. The unit operated to manufacturer specifications and was returned to clinical use. The suspect part was returned to the manufacturer. If additional information becomes available on this complaint that would alter the facts and/or conclusion, a follow-up emdr will be filed accordingly.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1828100-2016-00128
MDR Report Key5464225
Date Received2016-02-26
Date of Report2016-04-20
Date Mfgr Received2016-03-29
Date Added to Maude2016-02-26
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
Manufacturer Phone7346634145
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 Received2016-02-26
Returned To Mfg2016-04-06
Model Number5773
Catalog Number5773
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTERUMO CARDIOVASCULAR SYSTEMS CORP.
Manufacturer Address6200 JACKSON ROAD ANN ARBOR MI 48103 US 48103


Patients

Patient NumberTreatmentOutcomeDate
10 2016-02-26

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