MAUDE Adverse Event Report: TERUMO BCT COBE SPECTRA; COBE SPECTRA RBCX SET

Catalog Number 70700

Device Problems Complete Blockage (1094); Device Displays Incorrect Message (2591)

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

Event Date 10/30/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that during a procedure, she was having access problems with the patient's catheter and was getting 'return pressure high' and 'centrifuge pressure high' alarms.The customer reported being able to see clots in the access and return lines.The procedure could not be continued because of the clots in the set.The customer planned to call the doctor and restart the procedure with a new set.Patient information and outcome are not available at this time.The disposable kit is not available for return, because it was discarded by the customer.

Manufacturer Narrative

Investigation: the lot number was not provided for this event, therefore,a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Root cause: the disposable kit was unavailable for further analysis.A definitive root cause for the clumping could not be determined.The extra-corporeal circuit in apheresis procedures may be inadequately anticoagulated due to, but not limited by, operator error, hypercoagulability patient physiology, using incorrect anticoagulant solution, or delivery errors due to failures in the apheresis systems.

Event Description

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

Manufacturer Narrative

This record was identified during a retrospective review of mdrs to identify records in which an event occurred, but the type of reportable event was not indicated appropriately.

• Brand Name: COBE SPECTRA
• Type of Device: COBE SPECTRA RBCX SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5247101
• MDR Text Key: 32101637
• Report Number: 1722028-2015-00620
• 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: 11/24/2015

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 Catalogue Number: 70700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2015
• Initial Date FDA Received: 11/24/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/15/2015; 07/30/2016
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other