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

Model Number 550AVHCT

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

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Per the manufacturer's technical support specialist, it was stated that there were inaccurate values and that the hematocrit saturation (h/sat) probe values displayed dashes.

Event Description

It was reported that the blood parameter monitor (bpm) displayed inaccurate values.No other details regarding the nature of this event were provided.

Manufacturer Narrative

The reported complaint could not be confirmed.The service repair technician (srt) was unable to verify the reported complaint.The arterial blood parameter monitor (bpm) and venous bpm passed intensity testing.Erasable electronically programmable read only memory (eeprom) did not list any critical error codes.The unit operated to the manufacturer's specifications.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

During laboratory analysis, the product surveillance technician was unable to verify the reported complaint.The monitor was powered up with no error codes displaying.Calibration and verification function was also successful.In-vivo adjustments were made to fine tune the on-screen values and all adjustments were made successfully.The monitor functioned as intended throughout the evaluation.

Event Description

Additional information was received that the hematocrit (hct) and oxygen saturation (svo2) were the values that were inaccurate.The reported issue occurred during set-up for a cardiopulmonary bypass (cpb) procedure.The surgical procedure was completed successfully.As mitigation, values were retrieved from a blood gas analyzer.There was no delay, no blood loss, nor adverse consequences to the patient.

• 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
• MDR Report Key: 10254411
• MDR Text Key: 202996298
• Report Number: 1828100-2020-00258
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• PMA/PMN Number: K182110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 550AVHCT
• Device Catalogue Number: 550AVHCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BLOOD GAS ANALYZER