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 Problems Failure to Charge (1085); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4) the reported complaint was confirmed.During the laboratory evaluation, the product surveillance technician (pst) found the cause of the failure to be due to leaking battery acid, which would eventually cause the battery to fail to function.The acid was observed to have leaked onto the battery casing/chassis and caused corrosion, though did not damage any other parts or functions.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 use of the device for a cardiopulmonary bypass procedure, the customer tried to charge battery on the blood parameter monitor (bpm) overnight and it did not hold a charge.This unit is currently being used for extracorporeal membrane oxygenation (ecmo).The device was not changed out, as they used the unit plugged in with the knowledge that the battery was not holding a charge.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per the clinical summary: according to chief perfusionist (ccp), the battery on this bpm would not hold a charge.Initially the depleted battery was discovered when transporting a patient from one unit to another.The bpm worked on alternating current (a/c) power, but when unplugged from a/c power the unit would die.According to the ccp, the bpm had to be recalibrated and the patient was transported with no bpm monitoring.There were no error messages associated with the battery issue.The customer continues to use the unit with the understanding that the battery is not holding a charge.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.

• 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: 5266918
• MDR Text Key: 32893010
• Report Number: 1828100-2015-01014
• 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: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• 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: 11/13/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2008
• 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