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 2014-06-25 for TERUMO CDI 100 MONITOR manufactured by Terumo Cardiovascular Systems Corp..

Event Text Entries

[16988207] It was reported that during use of the device for a cardiopulmonary bypass procedure, the blood parameter monitor (bpm) was not accurate. This issue has occurred a couple of times and exact dates are unk by customer. The device was not changed out, as the customer used a lab analyzer to finish the case. The surgical procedure was completed successfully. There were no delays, no blood loss, or no adverse consequences to the pt. Per the clinical review on (b)(6) 2014: after consultation with the clinical team, it was discovered that the clip on the h/sat probe was broken and the security of the probe to the cuvette was not ideal. This would at times lead to inaccurate data (both hematocrit and saturation). This was found by the perfusionist and the data was not used to clinically manage the pt. Add'l lab samples were taken to better monitor and manage these values. The case was completed successfully, without delay and without associated blood loss.
Patient Sequence No: 1, Text Type: D, B5


[17081126] Eval is in progress, but not yet concluded.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1828100-2014-00542
MDR Report Key3966259
Report Source05,06
Date Received2014-06-25
Date of Report2014-06-02
Date of Event2014-01-01
Date Mfgr Received2014-06-02
Date Added to Maude2014-08-14
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 Received2014-06-25
Returned To Mfg2014-06-17
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 2014-06-25

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