MAUDE Adverse Event Report: TERUMO BCT COBE SPECTRA BLOOD COLLECTION; COBE SPECTRA APHERESIS SYSTEM

Model Number 000000000950000000

Device Problem Insufficient Information (3190)

Patient Problems Bradycardia (1751); Nausea (1970); Loss Of Pulse (2562)

Event Date 12/23/2013

Event Type  Injury  

Event Description

The customer reported that 10 minutes into a therapeutic plasma exchange (tpe) procedure,the patient complained of nausea, then went bradycardic then pulseless.Cpr was administered and patient was given epinephrine per the attending physician.She was then admitted to the intensive care unit for 2 days.The customer reports that the patient is now in stable condition.This report is being filed due to the patient coding, which required medical intervention and hospitalization for 2 days.

Manufacturer Narrative

Investigation: the customer's biomed requested guidance on which portion of the preventative maintenance (pm) procedure to perform on the device following the event for machine checkout.Terumo bct technical support advised the biomed to perform all calibration and functional checks from the pm and to perform a saline run.The customer does not believe the machine or the disposable to be the cause of the patient code.No other similar reports have been received for this device.A one-year machine service history review did not reveal any reported issues with this device.Root cause: a definitive root cause could not be determined at this time.No issues were noted with the device in its service history.

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 in the mdr form.This supplement is being filed to modify information, per fda request.

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: kristen cohen ; 10811 w collins avenue; lakewood, CO 80215 ; 3032052870
• MDR Report Key: 3585404
• MDR Text Key: 4163685
• Report Number: 1722028-2014-00016
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK960076
• 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
• Report Date: 12/23/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 000000000950000000
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2013
• Initial Date FDA Received: 01/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/1998
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 00036 YR
• Patient Weight: 45