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 Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2020

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the hematocrit (hct), hemoglobin (hb) and venous saturation values were drifting.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: the manufacturer's clinical specialist spoke with the perfusionist regarding an incident on (b)(6) 2020 that occurred during a cpb procedure with the blood parameter monitor (bpm).The bpm passed color chip without issue.Per the perfusionist, once cpb was commenced, dashes displayed on the monitor.The probe was removed from the cuvette and cleaned with a cloth.The probe was reattached and values appeared.Then the hb, hct and venous saturation values were off.He did take a venous in-vivo (he normally does not in-vivo the venous saturation, but does hct and hb, but had on this case) when the issue was observed.On initiation of this procedure, the venous saturation on the monitor was reading 70 and the first in-vivo blood gas was 83%.Significant drift on all three parameters occurred and in-vivo was redone.The perfusionist had to do in-vivo twice after his first one.He stated that he has a second bpm and he had seen no issues with that one.There was no harm or blood loss.The unit was not exchanged.There was no delay in the continuation of the surgical procedure.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed no drifting of the hematocrit saturation (h/sat) values and the unit to function to specification.The h/sat module performance was assessed using a static surface from which to reflect and read the light emitted by the probe, simulating a stable operating situation.Values were adjusted to sample values using the in-vivo readjustment (store/recall) function.The values as set remained steady overnight with a total operate time of approximately 14 hours.The h/sat values did not change during this time.

Manufacturer Narrative

The reported complaint could not be confirmed.During testing of the device at the service center, the service repair technician (srt) was not able to duplicate the reported complaint.The monitor was powered on and passed the self-test.The hematocrit saturation (h/sat) probe passed service mode testing.The arterial blood parameter monitor (bpm) probe passed intensity testing.The monitor passed all applicable testing.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.

• 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: 11146739
• MDR Text Key: 226026547
• Report Number: 1828100-2021-00011
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00886799001790
• UDI-Public: (01)00886799001790(11)200813
• 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
• Report Date: 08/09/2021

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: 550AHCT
• Device Catalogue Number: 550AHCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/11/2021
• Supplement Dates Manufacturer Received: 06/04/2021; 07/23/2021
• Supplement Dates FDA Received: 06/28/2021; 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1