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

Model Number 950000000

Device Problems Use of Incorrect Control/Treatment Settings (1126); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 11/02/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported an incident of data entry error in the cobe spectra machine.At the beginning of a collection procedure, the operator programmed the cobe spectra machine to collect 150 mls of plasma.During the procedure, she noticed that the machine was removing red cells instead of plasma.She realized that she had programmed the plasma flow rate to 150mls/min instead of 150mls of plasma.She restarted the collection procedure on a new disposable set, corrected the plasma pump and collected plasma and cells.Per the customer,the patient did well and there were no issues.Patient information is not available at this time.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: one year of service history was reviewed for this device with no problems identified that was related to the reported condition.An internal report indicates no further related issues have been reported for this device.Root cause: the root cause of this failure is 'user interface'.The customer programmed the low rate to 150ml/min of plasma instead of the target of 150ml of plasma.

Event Description

The customer did not respond to attempts to obtain information for the investigation such as, procedural details, patient information, and initial reporter's occupation.

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5250126
• MDR Text Key: 32160522
• Report Number: 1722028-2015-00622
• 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
• Report Date: 11/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 950000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other