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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 500AHCT
Device Problem Failure to Power Up (1476)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The reported complaint was confirmed. Per the user facility's biomedical technician, the original issue of the unit not powering up occurred sometime the week of (b)(6) 2021. During laboratory analysis, the product surveillance technician (pst) observed that the capacitor at c19 had failed which was the cause of the monitor not functioning. The charge indicator light on the back of the monitor was flashing and the monitor did not respond to the power switch. He checked the charging circuit output which was found to be unstable between zero and five volts direct current (vdc). He disassembled the monitor to access the power supply. With the auxiliary (aux) board disconnected, the output was 12vdc as expected. With the board connected, the output voltage was the same as from the charging circuit, fluctuating and low. He observed the capacitor at c19 to be shorted, causing a short circuit from the +12 power supply input to ground. The aux board had failed, preventing monitor function. The unit was determined to be end of service life (eosl) and will not be repaired. 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
It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the blood parameter monitor (bpm) had no power. As a result, an alternate device was employed. Upon further laboratory evaluation, a capacitor was found to be shorted out. 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 500
Type of DeviceMONITOR, 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 Key12281570
MDR Text Key265190074
Report Number1828100-2021-00268
Device Sequence Number1
Product Code DRY
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,health
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 08/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number500AHCT
Device Catalogue Number500AHCT
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/16/2000
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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