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

Model Number 500AHCT

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 01/14/2021

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the temperature measurement was not tracking properly.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Event Description

Per clinical review: the manufacturer clinical specialist spoke with the perfusionist regarding an incident the team had with the blood parameter monitor (bpm) during a cardiopulmonary bypass (cpb) procedure on (b)(6) 2021.During the procedure it was noted that the patient's temperature was approximately 28 degrees celsius, the bpm was reading seven degrees below what the patient's temperature was.The perfusionist team does understand per practice and understanding from use of the bpm for years, that the thermistor in the disposable and the corresponding reading does not correlate to patient temperature.The concern was the potential hydrogen (ph) and the partial pressure of carbon dioxide (pco2) post in-vivo was very inaccurate.The concern about the temperature being drastically different than what they would normally see on the bpm, cooling to the same temperature on various other surgeries.The team opted to exchange the unit and all values, including the temperature were trending as expected.There was no blood loss or harm associated with the event.There was no delay in the continuation of the surgical procedure.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed the bpm to power up and a 'f0a1' code logged in the erasable electronically programmable read only memory (eeprom).During visual inspection with a slight amount of lateral pressure, the tip of the thermistor detached from the arterial bpm.The tip of the thermistor was damaged resulting in poor temperature tracking.The product was sent to service to be brought to manufacturer¿s specifications before being returned to the customer.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 500
• Type of Device: MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 11294090
• MDR Text Key: 230759499
• Report Number: 1828100-2021-00037
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00886799001622
• UDI-Public: (01)00886799001622(11)170711
• Combination Product (y/n): N
• PMA/PMN Number: K133658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 500AHCT
• Device Catalogue Number: 500AHCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 02/08/2021
• Supplement Dates Manufacturer Received: 03/17/2021
• Supplement Dates FDA Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1