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 Unable to Obtain Readings (1516)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2020

Event Type  malfunction  

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed that the hemocrit saturation module (h/sat) was not functioning properly.Evidence of damage was found and the h/sat probe was opened to allow access to the exact location of the damage.There was evidence of damage from a heat source at the half inch cuvette position sensor.It was at the time of finding the heat damage on (b)(6) 2020 to make this complaint mdr reportable.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the blood parameter monitor (bpm) displayed an error message and the venous saturation probe would no longer read the parameters.As a result, an alternative device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: on (b)(6) 2020 during a cpb procedure, the perfusion team had a bpm that gave an error code and disabled the venous saturation parameters.The team powered on and set up the bpm without issue for a procedure.Cpb was initiated and shortly afterwards the bpm gave the perfusionist an error code that they cannot recall.The bpm disabled the venous saturation numbers.The team opted to exchange the unit during the procedure.There was no delay in the continuation of the surgical procedure.There was no harm or blood loss associated with the event.

• 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
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 11111339
• MDR Text Key: 225730704
• Report Number: 1828100-2021-00001
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• 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: 12/04/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1