MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA APHERESIS SYSTEM

Model Number 61000

Device Problems Failure to Shut Off (2939); No Apparent Adverse Event (3189)

Patient Problems Venipuncture (2129); No Consequences Or Impact To Patient (2199)

Event Date 05/13/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: the machine was checked out at the customer site by a terumo bct technician.The technician calibrated and checked all pressure sensors, ran a pump occlusion test, rant a valve and cassette autotest, ran fluid with a disposable set, checked pressure alarm, and tested power off.All tests passed.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a platelet collection procedure, the return pump did not stop when the pump was set to 0ml/min by the operator.Per the customer, the patient's vein broke.It is unknown at this time if medical intervention was required for this event.Patient information and outcome not available at this time.

Event Description

After follow up with the customer, the customer confirmed that no medical intervention was necessary for this event.Per the customer, this was a common case where an inefficient puncture, bruising or arm movement occurs during common blood removal or platelet donation.No further medical attention required any more monitoring by technical/medical personnel in this case.The donor disconnected when the vein ruptured and was attended at the time by the hemotherapy technician and the hemotherapist who were performing the procedure.The usual treatement was done and the puncture site was compressed.It was recommended not to exert with that arm for the rest of the day and to make cold applications (ice, gel) in place.Customer declined to provide patient (donor) information.The donor was fine and was sent home with instuctions about the hematoma.

Manufacturer Narrative

This report is being filed to provide additional information in h6 & h10.Investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.No medical intervention was necessary for this event.The device serial number history report indicates no further related issues have been reported for this device.Several platelet collection procedures and other protocols have been performed successfully after this event.One year of service history was reviewed for this device with no issues related to the reported condition identified.Per customer follow-up, after the incident the technician performed the intervention of the optia team and carried out the checks detailed in the report, the pressures of the sensors were within the normal range, they were also re- calibrated.Several platelet collection procedures and other protocols have been performed after this event successfully.Root cause: a definitive root cause could not be determined.Possible causes include but are not limited to: phlebotomy technique causing the needle to unintentionally enter the tissue surrounding the blood vessel.Dislodgement of the needle from the vein due to arm movement, a poorly secured needle, or an inadequate choice of venous site to puncture.An excessively high return flow rate.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10123438
• MDR Text Key: 200867401
• Report Number: 1722028-2020-00275
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583610002
• UDI-Public: 05020583610002
• Combination Product (y/n): N
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/05/2020

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: 61000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/13/2020
• Initial Date FDA Received: 06/05/2020
• Supplement Dates Manufacturer Received: 10/08/2020
• Supplement Dates FDA Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other