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 500AV

Device Problems Fluid/Blood Leak (1250); Failure to Run on Battery (1466)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The reported issue was confirmed.During the laboratory evaluation, the bpm unit did not last the required 25 minutes of run-time on standby battery.The product surveillance technician (pst) charged the bpm unit's 12 volt (v) direct current (d/c) standby battery overnight to a minimum of eight plus hours.The bpm unit was placed in operate mode the following day, alternating current (a/c) power removed, the battery lasted less than 30 seconds and turned off immediately.The pst's inspection of the bpm unit's 12v battery revealed that it has leaked and fluid has been released onto rear chassis.The bpm unit's 12v d/c battery was defective; leaking and doesn't hold a charge to operate monitor.The product will be sent to service to be brought to manufacturers 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 set-up of the device for a cardiopulmonary bypass procedure, the battery back-up was not working on the blood parameter monitor (bpm).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.

• 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: 5584737
• MDR Text Key: 43585052
• Report Number: 1828100-2016-00259
• 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
• Type of Report: Initial
• Report Date: 04/18/2016

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: 500AV
• Device Catalogue Number: 500AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/07/2016
• Initial Date FDA Received: 04/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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