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

Catalog Number 70500

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/20/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a therapeutic plasma exchange (tpe) procedure, she received multiple alarms including 'centrifuge pressure high' and 'return pressure high' alarms and noticed the disposable set was clotted.She ended the procedure and a new disposable set was setup on the machine.The customer stated that she did not use the anti-coagulant(acda) solution for the procedure.Patient information and outcome is not available at this time.The disposable kit is not available for return, because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: during the initial complaint communication, the customer was instructed to follow the protocol for the specific solutions, noting that the clotting would continue if not done so.A review of the device history record for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: the cause of the centrifuge pressure high and the return pressure high alarms were caused by blood clotting in the kit.The clotted occurred due to the lack of a sufficient amount of anti-coagulant solution.

Manufacturer Narrative

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.The customer confirmed that the clotting occurred within the centrifuge.The location of the clot could not be returned to the patient.

Event Description

The customer did not respond to attempts to obtain information for the investigation such as procedural details, patient information, and patient outcome.

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA TPE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5503951
• MDR Text Key: 40784182
• Report Number: 1722028-2016-00129
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK080035
• 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,Followup,Followup
• Report Date: 03/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2019
• Device Catalogue Number: 70500
• Device Lot Number: 01Z15265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2016
• Initial Date FDA Received: 03/16/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/04/2016; 06/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2016
• 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