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

Catalog Number 70630

Device Problems Device Expiration Issue (1216); Inadequate User Interface (2958)

Patient Problem No Information (3190)

Event Date 06/22/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that they had to use an expired bone marrow processing (bmp) set since they did not have a non-expired bmp set available at the time of the procedure.The customer declined to provide procedural details and patient information.The customer declined to return the disposable set for investigation.

Manufacturer Narrative

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

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.Per terumo bct's internal documentation, sterilization of the product must be within two months before and two months after the date indicated on the product label.Therefore, although the product is labeled as having expired on june 1, 2016, its sterility is maintained through (b)(6) 2016 plus two months, or (b)(6) 2016.Therefore, there was no risk for use of the set at the time that the customer performed the procedure.According to the device history record, this kit went into the sterilization chamber on (b)(6) 2014 and its expiration date is listed as june 1, 2016.The date of the procedure was (b)(6) 2016.This is within the validated sterilization window of two years plus two months.Root cause: the customer did not have a kit available for use at the time of the procedure, and understood that the kit they used was expired.

Manufacturer Narrative

This report is being filed to provide additional information.Per terumo bct's internal documentation, spectra disposable sets stored for 2 years and 2 months and testing results concluded that the aging does not adversely affect the sterility or performance of the disposable nor does it cause any negative cytotoxicity effects.Updated root cause: the customer understood that the kit was expired and due to the customer's inventory management, an overnight shipment had to be requested.This shipment did not arrive in time for the procedure.

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA BONE MARROW SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w. collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5796250
• MDR Text Key: 50530023
• Report Number: 1722028-2016-00415
• 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,Followup
• Report Date: 07/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2016
• Device Catalogue Number: 70630
• Device Lot Number: 06W15242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2014
• 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