SHUNT SENSOR SYS500 CDI510H NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,06,07 report with the FDA on 2013-07-11 for SHUNT SENSOR SYS500 CDI510H NA manufactured by Terumo Cardiovascular Systems Corp..

Event Text Entries

[21672175] The user facility reported to terumo cardiovascular system that during cardiopulmonary bypass surgery, the shunt sensor leaked. Less than 1cc blood loss. Product was changed out. Surgery was successful.
Patient Sequence No: 1, Text Type: D, B5


[21913225] Upon eval of the device, the complaint was confirmed. The unit was performance tested, and the behavior of the unit was indicative of a leak. Visual inspection of the unit found that the dome was missing from the ph chemistry position. A review of the device history record could not be performed, as the lot number is unk. The most probable cause of the leak is that this particular unit was on the lower side of the adhesive injection volume for the primary adhesive ring. This unit was sufficiently cured and sealed to pass through our 100% leak test, but not enough to survive shipping, handling, and temperature/pressure changes. The most probable reason for the dome detachment is from shear stress inflicted by a pointed object that left marks on the polycarbonate. (b)(4). All available info has been placed on file in quality management for appropriate tracking, trending and follow up.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1124841-2013-00141
MDR Report Key3227128
Report Source00,01,05,06,07
Date Received2013-07-11
Date of Report2013-06-24
Date of Event2013-05-18
Date Mfgr Received2013-06-24
Date Added to Maude2013-10-02
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 ContactMICHAEL SILVESTRI, QUALITY DIR
Manufacturer Street125 BLUE BALL RD.
Manufacturer CityELKTON MD 21921
Manufacturer CountryUS
Manufacturer Postal21921
Manufacturer Phone8002623304
Manufacturer G1TERUMO CARDIOVASCULAR SYSTEMS CORP.
Manufacturer Street125 BLUE BALL RD.
Manufacturer CityELKTON MD 21921
Manufacturer CountryUS
Manufacturer Postal Code21921
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameSHUNT SENSOR SYS500
Generic NameBLOOD-GAS MONITOR
Product CodeDTY
Date Received2013-07-11
Returned To Mfg2013-06-27
Model NumberCDI510H
Catalog NumberNA
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeNA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTERUMO CARDIOVASCULAR SYSTEMS CORP.
Manufacturer Address125 BLUE BALL RD. ELKTON MD 21921 US 21921


Patients

Patient NumberTreatmentOutcomeDate
10 2013-07-11

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