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 2014-01-22 for TERUMO CDI 100 MONITOR manufactured by Terumo Cardiovascular Systems Corp..

Event Text Entries

[4549237] It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the hematocrit (hct)/ oxygen (o2) saturation monitoring display would go out after less than five minutes. The user would turn the unit off and plug it in, but it would still only run for less than five minutes. The device was not changed out, as the unit was not used for case. The surgical procedure was completed successfully, and there were no delays, no blood loss or no adverse consequences to the pt.
Patient Sequence No: 1, Text Type: D, B5


[11795080] This has been going on for a while. Exact dates were not documented by the customer. Upon receipt of the unit, it was noted that a cracked battery was in the unit and caused an intermittent failure due to battery acid leaking into the unit. This issue makes this complaint now reportable. 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 was present on the circuit board (acid is conductive and can create short circuit conditions) and is considered to have caused the blanking out issue. If additional info 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 Number1828100-2014-00041
MDR Report Key3747718
Report Source05,06
Date Received2014-01-22
Date of Report2014-01-16
Date of Event2013-01-01
Date Mfgr Received2014-01-21
Date Added to Maude2014-05-07
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 MONITOR
Generic NameCDI 100
Product CodeDTY
Date Received2014-01-22
Returned To Mfg2014-01-16
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 2014-01-22

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