MAUDE Adverse Event Report: TERUMO BCT TERUMO BCT; COBE 2991 CELL PROCESSING SET

Catalog Number 90819

Device Problems Fluid/Blood Leak (1250); Occlusion Within Device (1423); Material Perforation (2205); Material Twisted/Bent (2981); No Flow (2991)

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

Event Date 09/16/2015

Event Type  malfunction  

Event Description

On 09/16/2015, bmt laboratory received in autologous, hpc marrow cellular therapy product (ctp).The ctp was sampled for required testing and processing of the ctp was initiated to prepare the product for cryopreservation and subsequent storage in ln2 vapor phase storage for long-term storage until required for transplant.The ctp was processed on the cobe 2991 cell processor.The marrow product was dispensed into the terumo bct processing set centrifuge belt per protocol.This process requires multiple dispensing/centrifugation events to facilitate dispensing the entire ctp into the processing set.After the required centrifugation, the bmt technologists were attempting to press off the buffy coat into the post-process collection bag.When releasing the appropriate instrument valves to allow for the different ctp components to be pressed off, it was discovered that no fluids would move from the centrifuge belt into the tubing that branches to the various collection bags for waste/plasma/product.No visual obstructions were noted.In further troubleshooting the presumed obstruction to the fluid flow, the metal locking vice that supports and fixes the plastic processing set collar in place was released to allow for visual inspection of the tubing that extends below the collar into the centrifuge belt.While manipulating the metal vice to release the collar to expose the tubing below, a leak was detected in the tubing immediately below the plastic collar.The bmt technologists immediately removed the collar to allow for clamping of the tubing below the observed perforation.An estimated 15cc of product leaked from the perforation in the tubing.The centrifuge belt was removed from the instrument and the product was transferred to the appropriate sized transfer bag for continuation of processing on a backup instrument.Very little cell loss was observed in assessing the pre-process tnc compared to that of the post-process tnc.Post-process sterility testing results are pending as of 09/23/2015.Upon further inspection of the terumo bct processing set, twisting of the tubing just below the collar was observed and was found to occlude flow of any fluid through the twisted portion of the tubing explaining why the technologists were unable to press "of" any fluids during the procedure.Report: (b)(4).

• Brand Name: TERUMO BCT
• Type of Device: COBE 2991 CELL PROCESSING SET
• Manufacturer (Section D): TERUMO BCT; 10810 west collins avenue; lakewood CO 80215
• MDR Report Key: 5161733
• MDR Text Key: 28852873
• Report Number: MW5057192
• Device Sequence Number: 1
• Product Code: LKN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/23/2015

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: 09/01/2016
• Device Catalogue Number: 90819
• Device Lot Number: 09W15001
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 41