MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI BLOOD PARAMETER MONITORING SYSTEM 550; CARDIOPULMONARY 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 11/25/2020

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the blood parameter monitor (bpm) was not reading the values correctly.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, blood loss, nor adverse consequences to the patient.

Event Description

Per clinical review: the manufacturer's clinical specialist spoke with the perfusionist regarding issues they were having with their blood parameter monitor (bpm) on 25-nov-2020 during a cardiopulmonary bypass (cpb) procedure.On four different cases the potential hydrogen (ph), partial pressure oxygen (po2) and potassium values were out of range.The perfusionist stated that she does not do gas calibration and calibrates the shunt sensors per the instruction for use (ifu).The values that the team were getting from the blood gas analyzer were within normal range but the values would then drift to being very high or very low.The team were having to re-invivo calibrate numerous times during the procedure and the values were not trusted.During each of the four cases the units were exchanged out.There was no harm or blood loss due to the occurrences.The was no delay in the continuation of the surgical procedure.

Manufacturer Narrative

Updated blocks: b5 and d9.

Manufacturer Narrative

Updated blocks: h3 and h6.During laboratory analysis, the product surveillance technician (pst) did not observe any apparent issues with the monitor.The on-screen values could be adjusted using the store/recall function.The values, once adjusted, did not change during the evaluation.

Manufacturer Narrative

The reported complaint could not be confirmed.The service repair technician was unable to duplicate the reported complaint.He observed the monitor to power on and pass all self-tests.The hematocrit saturation probe passed during service mode testing and the arterial probe during intensity testing.No errors or irregular values were displayed during 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: CARDIOPULMONARY BYPASS ON-LINE BLOOD GAS
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 11057249
• MDR Text Key: 224149641
• Report Number: 1828100-2020-00494
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00886799001790
• UDI-Public: (01)00886799001790(11)190217
• Combination Product (y/n): N
• PMA/PMN Number: K182110
• 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: 04/13/2021

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: 01/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 01/04/2021; 01/27/2021; 04/05/2021
• Supplement Dates FDA Received: 01/25/2021; 02/18/2021; 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1