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 Type  malfunction  

Manufacturer Narrative

Per the manufacturer's sales representative, the irregular readings on the venous side have been an issue with the unit since they received it about a month previous to (b)(6) 2020.The end user has continued to use the unit despite the irregularities.

Event Description

It was reported that during cardiopulmonary bypass (cpb) procedure, the unit displayed inaccurate venous readings.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 discussed with the perfusionist about the concern he had with the blood parameter monitor (bpm).The bpm passed its color chip without issue.The date is not known on this issue, but there has been an additional complaint for (b)(6) 2020 with the same unit and clinical situation.The perfusionist, once commencing cpb, saw dashes on his monitor.He took the probe off from the cuvette and cleaned it with a cloth, then reattached it and the values appeared.He stated then his hemoglobin (hb), hematocrit (hct) and venous saturation values were off.He took a venous in-vivo (he normally does not invivo venous saturation, but does hct and hb.He did on this case and when he sees the issue).He then saw some significant drift on all three parameters and re-did the in-vivo, which he did twice post the first one.He stated he has a second bpm, and has seen no issues with that unit.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: 11059678
• MDR Text Key: 226349984
• Report Number: 1828100-2020-00498
• 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

• Date FDA Received: 12/22/2020
• 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
• Date Manufacturer Received: 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1