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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 500; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI BLOOD PARAMETER MONITORING SYSTEM 500; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500 Back to Search Results
Model Number 500AVHCT
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2021
Event Type  malfunction  
Manufacturer Narrative
The reported complaint was confirmed.Per the srt, during oven testing when the bpm was held in a 20 degree celsius environment it was reading 7.8 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.
 
Manufacturer Narrative
The reported complaint was confirmed.Per the srt, during oven testing when the bpm was held in a 20 degree celsius environment it was reading 7.8 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 Name
CDI BLOOD PARAMETER MONITORING SYSTEM 500
Type of Device
MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500
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 Key13238031
MDR Text Key286021679
Report Number1828100-2022-00015
Device Sequence Number1
Product Code DRY
UDI-Device Identifier00886799001646
UDI-Public(01)00886799001646(11)171114
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 01/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number500AVHCT
Device Catalogue Number500AVHCT
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/22/2021
Initial Date FDA Received01/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/14/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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