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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI BLOOD PARAMETER MONITORING SYSTEM 550 CARDIOPULMONARY BYPASS ON-LINE BLOOD GAS

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI BLOOD PARAMETER MONITORING SYSTEM 550 CARDIOPULMONARY BYPASS ON-LINE BLOOD GAS Back to Search Results
Model Number 550AVHCT
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/22/2021
Event Type  malfunction  
Manufacturer Narrative
The reported complaint was confirmed. Per the srt, during oven testing when the bpm was held in a 20 degrees celsius environment it was reading 14. 9 degrees celsius which is outside of the specification range. The srt replaced the venous bpm probe. The unit operated to the manufacturer's specifications. If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
 
Event Description
The service repair technician (srt) reported that during testing of the device at the service center, the venous blood parameter monitor (bpm) probe failed measured temperature accuracy testing. There was no patient involvement.
 
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Brand NameCDI BLOOD PARAMETER MONITORING SYSTEM 550
Type of DeviceCARDIOPULMONARY BYPASS ON-LINE BLOOD GAS
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 Key13012464
MDR Text Key284022584
Report Number1828100-2021-00471
Device Sequence Number1
Product Code DRY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number550AVHCT
Device Catalogue Number550AVHCT
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/15/2019
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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