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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI 100 HEMATOCRIT/OXYGEN SATURATION MONITORING SYSTEM MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI 100 HEMATOCRIT/OXYGEN

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI 100 HEMATOCRIT/OXYGEN SATURATION MONITORING SYSTEM MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI 100 HEMATOCRIT/OXYGEN Back to Search Results
Model Number 100
Device Problem Corroded (1131)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/07/2018
Event Type  malfunction  
Event Description
It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the blood parameter monitor (bpm) battery was no longer working and had a corroded power pack. As a result, an alternate device was employed. The surgical procedure was completed successfully. There was no delay, no blood loss, nor adverse consequences to the patient.
 
Manufacturer Narrative
The reported complaint was not verifiable. Multiple attempts for part return and additional information have been unsuccessful. If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
 
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Brand NameCDI 100 HEMATOCRIT/OXYGEN SATURATION MONITORING SYSTEM
Type of DeviceMONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI 100 HEMATOCRIT/OXYGEN
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
6200 jackson road
ann arbor MI 48103
Manufacturer (Section G)
SAME
Manufacturer Contact
douglas patton
6200 jackson road
ann arbor, MI 48103
7346634145
MDR Report Key7832566
MDR Text Key118753474
Report Number1828100-2018-00454
Device Sequence Number1
Product Code DRY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K902654
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number100
Device Catalogue Number100
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/01/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/18/1994
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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