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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 Resultor Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/05/2021
Event Type  malfunction  
Manufacturer Narrative
Per the manufacturer's subsidiary, the temperature was unstable, showing 40 degrees celsius during hypothermia. The flow rate was approximately three liters per min (l/min). About 10 minutes before the ventilator was removed, there was a noticeable difference in measurement. The bpm showed that the be was -8, while the laboratory machine showed that the be was -2. 5. During cpb, the laboratory machine data was used to correct the values on the bpm. Recalibration was preformed, but there was no improvement.
 
Event Description
It was reported that during use of the device for cardiopulmonary bypass (cpb) the blood parameter monitor (bpm) displayed abnormal temperature and base excess (be) values. The surgical procedure was completed successfully. There was no delay, no blood loss, nor adverse consequences to the patient.
 
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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 Key12897133
MDR Text Key281589273
Report Number1828100-2021-00455
Device Sequence Number1
Product Code DRY
Combination Product (y/n)N
Reporter Country CodeJA
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,Followup,Followup
Report Date 06/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received05/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/23/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 11/30/2021 Patient Sequence Number: 1
Treatment
BLOOD GAS ANALYZER
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