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

Model Number 71000

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

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

Event Date 09/26/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that during setup of a therapeutic plasma exchange (tpe) procedure,they received a 'plasma pump error' alarm.While the operator was troubleshooting, she discovered that she had inadvertently selected a white blood cell (wbc) collection procedure on the machine instead of a tpe procedure.The operator unloaded the tpe set, loaded it again, and selected the correct tpe procedure.Patient information is not available at this time.

Manufacturer Narrative

This report is being filed to provide additional information in evaluation codes, additional mfr narrative, and corrected information in occupation.Investigation: a review of the last year of service history for this device indicated no other reports related to this issue.An internal report shows that the machine has been in use with no further occurrences of the problem.Root cause: the root cause of this failure was a data entry error where the operator selected the wrong tubing set on the machine screen during device setup.

Manufacturer Narrative

This report is being filed to provide additional information in pt identifier, describe event or problem, occupation, and additional mfr narrative.Additional investigation: the device alarmed as intended; the reported event resulted in a fail safe condition.

Event Description

The alarms occurred during prime, prior to donor connect, during device setup.Therefore, no donor was connected at the time of the event.No patient (donor) information is reasonably known.

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10811 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6036659
• MDR Text Key: 57918875
• Report Number: 1722028-2016-00566
• 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: 10/18/2016

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 Model Number: 71000
• Other Device ID Number: 05020583710009
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2016
• Initial Date FDA Received: 10/18/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/13/2017; 02/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other