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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 Problems Thermal Decomposition of Device (1071); Failure to Power Up (1476)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/21/2021
Event Type  malfunction  
Event Description
It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the blood parameter monitor (bpm) would not turn on. As a result, an alternate device was employed. No further details regarding the nature of this event were provided. During laboratory evaluation of the unit, it was found that an internal capacitor had failed and showed signs of damage from overheating.
 
Manufacturer Narrative
Per the user facility's biomedical technician, the unit only had a green light lit on the back and did not have an audible tone when booting up like normal, only a black screen. During laboratory evaluation of the device, the product surveillance technician (pst) observed the monitor to not power on, but the charge indicator light was on, which meant the power supply was functioning properly. He disassembled the unit and found a damaged capacitor at the c137 position on the auxiliary (aux) printed circuit board (pcb). There was a short circuit condition between the 12 volt (v) switch and ground across the capacitor causing it to fail. The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.
 
Manufacturer Narrative
The reported complaint was confirmed. Per supplier evaluation, the printed circuit board assembly (pcba) was visually inspected upon receipt where it was determined there was a burned capacitor at location c137 and a missing transistor at location q10. The board was not tested as it was expected to fail due to the visual defects found. The pads at location q10 showed evidence in the solder left that there the transistor was placed and soldered there. Based on device history records, the board was fully functional upon initial shipment to the manufacturer. If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
 
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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 Key13059179
MDR Text Key284683474
Report Number1828100-2021-00487
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 Health Professional,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 06/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/20/2020
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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