MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI BLOOD PARAMETER MONITORING SYSTEM 550; CARDIOPULMONARY BYPASS ON-LINE BLOOD GAS

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.

Manufacturer Narrative

The service repair technician (srt) duplicated the reported complaint.The cause was a defective auxiliary (aux) printed circuit board assembly (pcba) board.The srt replaced the aux pcba board and the monitor powered up successfully.The unit operated to the manufacturer's specifications.

• 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 Key: 13059179
• MDR Text Key: 284683474
• Report Number: 1828100-2021-00487
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00886799001790
• UDI-Public: (01)00886799001790(11)201120
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182110
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 550AHCT
• Device Catalogue Number: 550AHCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1