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 500AVHCT

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2019

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure the temperature reading was inaccurate.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.During the procedure it was noticed that the temperature reading was at approximately 40.5 degrees celsius.The patient had been cooled, and re-warmed during the procedure, at a range of 32 and 37 degrees celsius.It was noted that all other parameters were within expected range during the rest of the surgery.It was discussed what the temperature of the shunt sensor reflects, and it was reiterated that the perfusionist does not use this as patient temperatures, and no patient decisions were based upon this value.The unit was not exchanged during the procedure, and was noticed on a few other procedures, as noted in the occurrence rate.There was no harm or blood loss associated with the issue.

Manufacturer Narrative

H3: 81 evaluation is in progress, but not yet concluded.

Manufacturer Narrative

During the laboratory analysis, the product surveillance technician (pst) observed the customer's blood parameter monitor (bpm) temperature measurement accuracy comparable to that of the reference bpm in the laboratory.There were no obvious issues with the thermistor, and no bpm nor thermistor-related error codes in erasable electronically programmable read only memory (eeprom).

Manufacturer Narrative

The reported complaint could not be confirmed.The service repair technician was unable to duplicate the reported issue.The temperature remained accurate throughout evaluation.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: 9502717
• MDR Text Key: 199261404
• Report Number: 1828100-2019-00680
• Device Sequence Number: 1
• Product Code: DRY
• 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,Followup,Followup
• Report Date: 05/12/2020

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: 500AVHCT
• Device Catalogue Number: 500AVHCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 12/26/2019; 01/31/2020; 05/04/2020
• Supplement Dates FDA Received: 01/20/2020; 02/25/2020; 05/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1