SHUNT SENSOR SYS500 CDI510H N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-03-11 for SHUNT SENSOR SYS500 CDI510H N/A manufactured by Terumo Cardiovascular Systems Corporation.

Event Text Entries

[139104496] Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed. Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[139104517] The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during out of box, leakage was found when the shunt sensor was unpacked. No patient involvement as this occurred during out of box..
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1124841-2019-00068
MDR Report Key8409806
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-03-11
Date of Report2019-04-26
Date of Event2019-02-21
Date Mfgr Received2019-04-23
Device Manufacturer Date2018-07-03
Date Added to Maude2019-03-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. CATHLEEN HARGREAVES
Manufacturer Street125 BLUE BALL ROAD
Manufacturer CityELKTON MD 21921
Manufacturer CountryUS
Manufacturer Postal21921
Manufacturer Phone8002837866
Manufacturer G1SAME
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSHUNT SENSOR SYS500
Generic NameBLOOD GAS MONITOR
Product CodeDRY
Date Received2019-03-11
Returned To Mfg2019-03-11
Model NumberCDI510H
Catalog NumberN/A
Lot NumberWG11D
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerTERUMO CARDIOVASCULAR SYSTEMS CORPORATION
Manufacturer Address125 BLUE BALL ROAD ELKTON MD 21921 US 21921


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-11

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