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

Catalog Number 000000000777006000

Device Problem False Positive Result (1227)

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

Event Date 12/02/2014

Event Type  malfunction  

Event Description

The customer reported that they received positive blood cultures on an autologous stem cell product.Anaerobic cultures of the product after processing grew positive cultures for prevotella species.All other routine cultures of the product were negative.The product was discarded.No medical intervention was necessary for this event and did not require any further follow-up visit.The patient is reported in stable condition.The customer declined to provide the patient's identifier.The disposable set is not available for return as the customer discarded it.This report is being filed due to bacterial contamination.

Manufacturer Narrative

Investigation: per the customer, the patient was remobilized and will undergo another collection.Per the customer, routine cultures were done at time of central line placement.They were negative.355mls of product was collected.Patient did fine.No problems.Product was sent for processing.Routine cultures were done pre-processing and were negative.The routine anaerobic cultures done after processing prior to cryopreservation, came up positive for prevotella species.The aerobic cultures were negative.The product was not used.The customer reported that the positive anaerobic culture was a 'prevotella' species.Prevotella species are anaerobic gram-negative bacilli (agnb) and are part of normal oral flora.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: this disposable set was unavailable for specific root cause analysis.The customer stated that all tests were negative except for post-processing anaerobic cultures.Pre-processing cultures were negative.Root cause for the bacterial contamination is inconclusive but may be related to customer lab processing, sampling, or handling of the product after the mnc collection.

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 BLOOD COLLECTION
• Type of Device: COBE SPECTRA WHITE BLOOD CELL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: glenda o'neill ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 4471350
• MDR Text Key: 5565576
• Report Number: 1722028-2015-00039
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK020041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/13/2015

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 Expiration Date: 06/01/2016
• Device Catalogue Number: 000000000777006000
• Device Lot Number: 06W15250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2015
• Initial Date FDA Received: 01/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2014
• 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
• Patient Age: 00065 YR
• Patient Weight: 74