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

Catalog Number 70600

Device Problems Device Expiration Issue (1216); Device Displays Incorrect Message (2591); Inadequate User Interface (2958)

Patient Problems No Patient Involvement (2645); No Information (3190)

Event Date 03/07/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer initially reported that during prime of a white blood cell (wbc) collection procedure, they were unable to continue a procedure due to an alarm and a new wbc disposable set was used.While investigating, it was discovered that the customer had used an expired set.The set expired on 09/2016.Patient information and outcome are not available at this time.The wbc collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information.Root cause: the root cause for the use of an expired set is related to user error in setting up an expired set for a procedure.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: one primed cobe spectra wbc disposable set was received for investigation.It was noted that the access and return saline spike receptors and the ac spike receptor had been rf sealed and removed by the customer.Prime fluid was also observed throughout the disposable.Visual examination of the disposable confirmed that batch (b)(4) with expiry 2016-09-01 had been used.The disposable was further examined for any kinks, leaks, occlusions, missing part or other misassembly and none were found.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: a terumo bct representative contacted the customer to confirm the lot number and incident date since the incident date reported by the customer was after the expiration date.The customer confirmed on july 23, 2017 that it was the correct lot number.The lot number expiration date is 9/1/2016 but the incident date was reported as (b)(6) 2017.The lot was sent to the customer on 2/11/2015.Investigation is in process.A follow-up report will be provided.

Event Description

No patient (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 WHITE BLOOD CELL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6800766
• MDR Text Key: 83318197
• Report Number: 1722028-2017-00330
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• PMA/PMN Number: BK020041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2016
• Device Catalogue Number: 70600
• Device Lot Number: 09W15276
• Other Device ID Number: 05020583706002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2014
• 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