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 2013-09-13 for TERUMO CDI 100 MONITOR manufactured by Terumo Cardiovascular Systems Corp..

Event Text Entries

[3878064] It was reported that during priming of the device for a cardiopulmonary bypass procedure, the a/d (analog to digital conversion) test failed on the blood parameter monitor (bpm). As a result, an alternate device was employed. The surgical procedure was completed successfully, and there were no delays, no blood loss or no adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5


[11127285] This complaint was confirmed by the product surveillance lab tech. The a/d (analog to digital conversion) test failure error was observed and was occurred during the power up self-test. Visual inspection found a cracked battery that had leaked acid. The battery leaking was confirmed to have reached the pcba. Battery acid has damaged the circuits and was present on the circuit board. The battery acid was considered to have caused the a/d failure on the pcba. This product is being phased out in the global market. Service and replacement parts are no longer available. If add'l 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 Number1828100-2013-00866
MDR Report Key3396396
Report Source05,06
Date Received2013-09-13
Date of Report2013-09-06
Date of Event2013-04-15
Date Mfgr Received2013-09-06
Date Added to Maude2013-12-19
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 FDA0
Event Location0
Manufacturer ContactJAN WINDER
Manufacturer Street6200 JACKSON RD.
Manufacturer CityANN ARBOR MI 48103
Manufacturer CountryUS
Manufacturer Postal48103
Manufacturer Phone7346634145
Manufacturer G1TERUMO CARDIOVASCULAR SYSTEMS CORP.
Manufacturer Street6200 JACKSON RD.
Manufacturer CityANN ARBOR MI 48103
Manufacturer CountryUS
Manufacturer Postal Code48103
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTERUMO CDI 100 MONITOR
Product CodeDTY
Date Received2013-09-13
Returned To Mfg2013-06-17
Model Number100
Catalog Number100
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTERUMO CARDIOVASCULAR SYSTEMS CORP.
Manufacturer Address6200 JACKSON RD. ANN ARBOR MI 48103 US 48103


Patients

Patient NumberTreatmentOutcomeDate
10 2013-09-13

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