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

Model Number 550AHCT

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the hematocrit (hct) values post in-vivo were approximately six to ten points off from blood gases.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: it was unknown when this occurred, but about half of the cases between march or april until now, the blood parameter monitor (bpm) has been giving the perfusion team about a six to ten point difference in the hct values.The unit passes its color chip test without issue.They re-invivo the units with the first blood gas, and "hematocrit drift" has been noted.In some instances it was between 6 and 10 points, but in others it does get better with repeated in-vivo calibrations.The unit has not been exchanged out on the cases.There has not been a delay in these surgical procedures, and no blood loss or harm has been reported due to this concern.

Manufacturer Narrative

81 evaluation is in progress, but not yet concluded.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) was unable to duplicate the reported complaint.He performed several sample in-vivo recalibrations and the hematocrit value could be set to any value throughout the display range of the parameters.The service repair technician (srt) was also unable to duplicate the reported complaint.He replaced the hematocrit saturation (h/sat) as precautionary measure.The unit operated to the manufacturer's specifications.

Manufacturer Narrative

The reported complaint could not be confirmed.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: CARIDOPULMONARY BYPASS ON-LINE BLOOD GAS
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 9382844
• MDR Text Key: 207786917
• Report Number: 1828100-2019-00629
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00886799001790
• UDI-Public: (01)00886799001790(11)190208
• 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: 04/07/2020

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: 550AHCT
• Device Catalogue Number: 550AHCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 11/27/2019
• Supplement Dates Manufacturer Received: 01/14/2020; 02/21/2020; 03/19/2020
• Supplement Dates FDA Received: 02/06/2020; 03/17/2020; 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BLOOD GAS ANALYZER