MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO CDI 500 BLOOD PARAMETER MONITOR

Model Number 500AHCT

Device Problem Data Problem (3196)

Patient Problem Blood Loss (2597)

Event Type  malfunction  

Event Description

It was reported that during extracorporeal membrane oxygenation (ecmo), the saturated venous oxygen ( svo2) was registering inaccurate.As a result, and alternate device was employed.The surgical procedure was completed successfully.There was blood loss and no adverse consequences to the patient.Per clinical review on (b)(6) 2014, the hematocrit in an ecmo (extra corporeal membrane oxygenation) circuit.Ecmo was initiated in the early hours of (b)(6)2014 and this incident occurred near 10:00 am on (b)(6) 2014.The reported issue was saturated venous oxygen (svo2) was being measured and displayed as 100 percent, whereas the lab analyzed value was 70 percent.Normal svo2 levels are 65 to 75 percent, so the 100 percent value was detected bythe user as not reasonable.In-vivo re-calibrations were done, a number of ties, but within 30 minutes the blood parameter monitor (bpm) measurement was again reading 100 percent.The ecmo technician elected to change out the bpm.The disposable cuvette was not changed.After the bpm change out, the svo2 provided reasonable and expected measurements.The ecmo procedure was completed and this did not delay the procedure.There was no associated blood loss and there was no associated with this incident.

Manufacturer Narrative

This complaint is related to mdr #1828100-2014-00794.

• Brand Name: TERUMO CDI 500 BLOOD PARAMETER MONITOR
• Type of Device: CDI 500
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4138649
• MDR Text Key: 4915939
• Report Number: 1828100-2014-00801
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/09/2014

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: 500AHCT
• Device Catalogue Number: 200AHCT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2014
• Initial Date FDA Received: 10/01/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2004
• 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
• Treatment: LABORATORY ANALYZER