MAUDE Adverse Event Report: TERUMO BCT COBE SPECTRA BLOOD COLLECTION; COBE SPECTRA WHITE BLOOD CELL SET

Catalog Number 777006000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Diaphoresis (2452)

Event Date 06/20/2016

Event Type  Injury  

Manufacturer Narrative

Investigation: per the american association of blood banks (aabb) therapeutic apheresis: a physician's handbook,t he rate of adverse events during therapeutic apheresis is 4-5% with the risk being slightly higher during a first-time procedure.Within the study, most complications were minor and well tolerated.A review of the device history record for this lot showed no irregularities during manufacturing that were relevant to this issue.Terumo bct performed an autotest and full simulated run on the machine involved in this event.No issues were found.Root cause: the available evidence points to the reactions as being vasovagal and physiologic responses to the apheresis procedures.

Event Description

The customer reported that a patient had a reaction during a mononuclear cell (mnc) collection during an mnc research procedure.The patient became diaphoretic and hypotensive after the first attempt to place peripheral iv.This was the patient's first donation procedure.This initial reaction was resolved.One hour and ten minutes after the start of the procedure, the patient complained of dizziness and was hypotensive.One liter of normal saline was administered as a bolus.The customer suspects vasovagal reaction.The procedure was ended when adequate access was lost at 5,200ml and the procedure was not restarted.The patient was discharged on the same day as his values returned to his healthy baseline.The disposable set is not available for return, because it was discarded by the customer.

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA WHITE BLOOD CELL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5816918
• MDR Text Key: 50292478
• Report Number: 1722028-2016-00425
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK020041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2018
• Device Catalogue Number: 777006000
• Device Lot Number: 02Z15207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00039 YR
• Patient Weight: 116