MAUDE Adverse Event Report: TERUMO BCT COBE 2991; COBE 2991 BLOOD CELL PROCESSING SYSTEM

Model Number 000000000912991000

Device Problem Insufficient Information (3190)

Patient Problems Dizziness (2194); Complaint, Ill-Defined (2331); Loss of consciousness (2418); Chest Tightness/Pressure (2463)

Event Date 03/03/2014

Event Type  Injury  

Event Description

The customer reported that the operator's pacemaker quits when standing close to the 2991 cell processor machine.The operator felt light-headed, dizziness, and tightness in her chest when the 2991 machine is turned on and is in close proximity to the machine.Per the customer, once she moves back at least 35 feet the symptoms resolve.The operator visited her cardiologist for follow-up.Per the cardiologist, heart rate is normal and no problems with the pacemaker.The operator is reported in healthy condition.The customer declined to provide the patient's (operator's) age and weight.This report is being filed due to medical intervention in the form of a visit to the operator's cardiologist.

Manufacturer Narrative

Investigation: per the customer, the operator has been working in the area for over 30 years.The pacemaker is new to her since (b)(6) 2013.They do not use the machine often.The 1st time it was used when she was present after having the pacemaker in (b)(6) 2014.She did not have any of the symptoms prior to having the pacemaker placed.Terumo bct notified the customer to discontinue using the device.A service call has been placed to check leakage current and grounding on the device.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Additional testing revealed that the 2991 device passed the international standard for radiated limits.This information was communicated back to the customer, and the device was returned to service.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: a one year review of the machine service history was performed and no records related to the reported condition were identified.The device was functionally tested at the customer site and no problems were found.A technical literature review conducted by terumo bct external electrical engineering standards consultant did not indicate that the device in this report may have led to the reported interference with the pacemaker.A review of 10 years worth of service data indicated this to be the only reported condition ofthis nature received.The customer reported that they completed their own investigation and do not believe the 2991 device is related to the cause of this issue.The operator has been evaluated by her cardiologist, as well as er staff, and occupational health with no evidence of her having any issues with her pacemaker or other side effects from the 2991 device.A request for the customer's internal investigation report as well as results of the cardiologist's examination was requested but due to confidentiality the customer stated they were unable to provide this documentation.Conclusion: a definitive root cause could not be determined at this time.Correction: a letter regarding 2991 emi was provided to the customer.Terumo bct sales offered to conduct additional testing on the device and the customer has accepted.

Manufacturer Narrative

This record was identified during a retrospective review of mdrs, per fda request, to identify records in which a serious injury or medical intervention occurred, but the type of reportable event was not indicated as a serious injury.

• Brand Name: COBE 2991
• Type of Device: COBE 2991 BLOOD CELL PROCESSING SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 3881953
• MDR Text Key: 4539116
• Report Number: 1722028-2014-00241
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K760856
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 000000000912991000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention