TERUMO CDI 100 MONITOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-04-29 for TERUMO CDI 100 MONITOR manufactured by Terumo Cardiovascular Systems Corp.

Event Text Entries

[3419501] After use of the device for a cardiopulmonary bypass procedure, the user reported the hematocrit saturation (h/sat) cable was fractured. There were no reported adverse consequences to the pt.
Patient Sequence No: 1, Text Type: D, B5


[10878851] Evaluation is in progress, but not yet concluded. Upon evaluation at the manufacturer. Found severe damage to the cable. Internal wires are broken and conductors are exposed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1828100-2013-00476
MDR Report Key3098880
Report Source05,06
Date Received2013-04-29
Date of Report2013-04-04
Date of Event2013-04-01
Date Mfgr Received2013-04-04
Date Added to Maude2013-07-02
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 FDA0
Event Location0
Manufacturer ContactTOM MYERS
Manufacturer Street6200 JACKSON RD.
Manufacturer CityANN ARBOR MI 48103
Manufacturer CountryUS
Manufacturer Postal48103
Manufacturer Phone7346634145
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTERUMO CDI 100 MONITOR
Product CodeDTY
Date Received2013-04-29
Model Number100
Catalog Number100
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerTERUMO CARDIOVASCULAR SYSTEMS CORP
Manufacturer AddressANN ARBOR MI 48103 US 48103


Patients

Patient NumberTreatmentOutcomeDate
10 2013-04-29

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