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

Model Number 550AHCT

Device Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/03/2021

Event Type  malfunction  

Event Description

It was reported that prior to use of the device for a cardiopulmonary bypass (cpb) procedure, the blood parameter monitor (bpm) emitted smoke followed by a burning smell.As a result, an alternate device was employed.There was more than an hour delay.The surgical procedure was completed successfully.There was no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

Updated blocks: d9, h3 and h6.During laboratory analysis, the product surveillance technician (pst) observed that one of the tantalum capacitors on the auxiliary printed circuit board (pcb) had failed.There was a short across the capacitor located on the battery charging circuit.There were no reference sensor failures and no error codes in the erasable electronically programmable read only memory (eeprom).The short did not prevent the monitor from functioning, as the system was booted successfully.The product was sent to service to be brought to manufacturer¿s specifications before being returned to the customer.

Manufacturer Narrative

Updated block: b5.

Event Description

Per clinical review: the team had an incident with the blood parameter monitor (bpm) prior to going on bypass on (b)(6) 2021.The unit emitted smoke then emitted a burning smell shortly after it was turned on.The clinician used another device, but there was a quoted time frame of an hour delay to the surgery.There was no harm or blood loss.

Manufacturer Narrative

The service repair technician (srt) observed the blood parameter monitor (bpm) to pass all self tests with no errors, but the unit was smoking due to the damaged capacitor.He verified that a capacitor on the auxiliary (aux) printed circuit board assembly (pcba) had failed.The aux pcba was replaced.The unit operated to the manufacturer's specifications.

Manufacturer Narrative

Updated block: h6 the reported complaint was confirmed.Per supplier evaluation, the burned capacitor was verified.The capacitor was oriented correctly on the board and there was no visual physical indicator for what may have caused the burning.The capacitor measured low resistance indicating a short did happen.The reason for the short was unknown.The printed circuit board assembly (pcba) had passed all tests and inspections and was fully functional when originally shipped 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.

• 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: 12078866
• MDR Text Key: 258756234
• Report Number: 1828100-2021-00219
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00886799001790
• UDI-Public: (01)00886799001790(11)200730
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K182110
• Number of Events Reported: 1
• 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,Followup,Followup
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• 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: 07/14/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2020
• 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