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 01,07 report with the FDA on 2013-02-14 for TERUMO CDI 100 MONITOR manufactured by Terumo Cardiovascular Systems Corp..

Event Text Entries

[3377821] It was reported that during prime of the device for a cardiopulmonary bypass procedure, the clip of hematocrit saturation (hct/sat) probe from the blood parameter monitoring (bpm) system had been broken off. Per the clinical review: the user reported that the hsat probe of the bpm system could not be clipped or secured to the disposable cuvette. Some troubleshooting was done and this did delay the preparation time of the cpb circuit, but likely did not delay the start of the surgical procedure. The device was not changed out, as the perfusionist used arterial blood gas for blood parameter monitoring. The surgical procedure was completed successfully, and there was no blood loss or no adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5


[10680487] Investigation in progress, but not yet completed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1828100-2013-00173
MDR Report Key3004384
Report Source01,07
Date Received2013-02-14
Date of Report2013-01-22
Date of Event2012-03-09
Date Mfgr Received2013-01-22
Date Added to Maude2013-04-02
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 ContactKIPP DURBIN
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 Received2013-02-14
Model Number100
Catalog Number100
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTERUMO CARDIOVASCULAR SYSTEMS CORP.
Manufacturer AddressANN ARBOR MI 48103 US 48103


Patients

Patient NumberTreatmentOutcomeDate
10 2013-02-14

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