MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. CDI BLOOD PARAMETER MONITORING SYSTEM 500; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500

Model Number 500AHCT

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure, the blood parameter monitor (bpm) shut off during case.The perfusionist (ccp) said it smelled a little hot before it shut off.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.

Event Description

Correction: the device was not changed out.Per the clinical review 08/17/2015: during a cardiopulmonary bypass (cpb) case, a blood parameter monitor (bpm) shut off.The perfusionist (ccp) stated that it smelled a little hot before it shut off.There was no visible smoke or fire.As a result, the ccp turned the power off and continued the case without a bpm.Additional blood gases where required.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.

Manufacturer Narrative

(b)(4).The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) found that the monitor would re-start while trying to complete the startup self-diagnostics.The auxilliary (aux) printed circuit board assembly (pcba) had an opened/burnt capacitor c59 disrupting the signal in the circuit.The product will be sent to service to be brought to manufacturers specifications before being returned to the customer.No additional action will be taken at this time.

• 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 CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5010678
• MDR Text Key: 24357874
• Report Number: 1828100-2015-00717
• 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 faci
• Reporter Occupation: Other
• Report Date: 10/15/2015

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: 500AHCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1