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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 550AHCT
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem Insufficient Information (4580)
Event Date 03/25/2024
Event Type  malfunction  
Event Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the blood parameter monitor (bpm) partial pressure of oxygen (po2) reading was dropping.There were no reported consequences to the patient.No other details regarding the nature of this event were provided.
 
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Brand Name
CDI BLOOD PARAMETER MONITORING SYSTEM 550
Type of Device
CARDIOPULMONARY 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 Key19132955
MDR Text Key340474327
Report Number1828100-2024-00117
Device Sequence Number1
Product Code DRY
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K182110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/18/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number550AHCT
Device Catalogue Number550AHCT
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/25/2024
Was Device Evaluated by Manufacturer? No
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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