TERUMO CDI 100 BLOOD 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 2014-04-28 for TERUMO CDI 100 BLOOD MONITOR manufactured by Terumo Cardiovascular Systems Corp..

Event Text Entries

[17281119] It was reported that during set-up of the device for a cardiopulmonary bypass procedure, after blood parameter monitor (bpm) was on a short time the screen faded out. As a result, an alternate device was employed. The surgical procedure was completed successfully. There were no delays, no blood loss, or no adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5


[17506385] The reported complaint was confirmed. A cracked battery was found that had leaked internal fluid. The battery leaking was confirmed to have reached the printed circuit board assembly (pcba). Battery acid has damaged the circuits and is present on the circuit board (acid is conductive and can create short circuit conditions) and is considered to have caused the failure. Product has been moved to service department for disposition, and will be scrapped. 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 Number1828100-2014-00357
MDR Report Key3869355
Report Source05,06
Date Received2014-04-28
Date of Report2014-04-21
Date of Event2013-12-09
Date Mfgr Received2014-04-21
Date Added to Maude2014-06-26
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 ContactJAN WINDER
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 BLOOD MONITOR
Generic NameCDI 100
Product CodeDTY
Date Received2014-04-28
Returned To Mfg2014-04-09
Model Number100
Catalog Number100
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTERUMO CARDIOVASCULAR SYSTEMS CORP.
Manufacturer AddressANN ARBOR MI 48103 US 48103


Patients

Patient NumberTreatmentOutcomeDate
10 2014-04-28

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