MAUDE Adverse Event Report: TERUMO BCT SCD IIB STERILE TUBING WELDER

Model Number 3NCC986

Device Problems Fluid/Blood Leak (1250); Microbial Contamination of Device (2303)

Patient Problem No Patient Involvement (2645)

Event Date 02/18/2015

Event Type  malfunction  

Event Description

The customer reported bacterial contamination in 4 bioreactors.While performing cho cell cultures and media, he noticed weld leaks during usage and observed moisture on the blade surfaces.Per the customer, no quality control (qc) testing was performed.The cells were examined by microscope and appeared to be microbial/bacteria.No patient or donor is connected to this device and no patient was placed at risk as this issue was found during qc testing therefore no patient information is reasonably known.

Manufacturer Narrative

Investigation: per the customer, the final inoculum and media were also used to run a satellite experiment that had no contamination issues.They examined the equipment used in the process and did not observe any ripped tubing or broken gaskets.After further investigation, they noticed that a sterile tubing welder they had used during the set up was not sealing properly.The customer performed a weld test with tubing containing water and observed water dripping down the blade.The same weld test was performed on a different welder with no issues.The welder was returned to terumo bct for servicing and investigation.Upon visual inspection,the welder was very 'dirty' and large pieces of tubing were found inside the welder.Many tube segments were found inside the welder causing the welder to not function properly.The tube segments were removed and the welder was cleaned.Test welds were made with no issues found.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event, based on investigational information.

Manufacturer Narrative

Investigation: one year of service history was reviewed and no additional reports related to the reported condition have been received.An internal report indicates no further related issues have been reported for this device.The customer stated that the product in question was not for human use.Additionally, product is tested prior to use on animals and humans as standard protocol in lab environments.Root cause: user interface.Correction: feedback was provided to the customer via e-mail regarding the operation of the scd iib welder.

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.

• Brand Name: SCD IIB STERILE TUBING WELDER
• Type of Device: SCD IIB STERILE TUBING WELDER
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: glenda o'neill ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 4682344
• MDR Text Key: 5678185
• Report Number: 1722028-2015-00135
• Device Sequence Number: 1
• Product Code: KSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK860041
• 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,Followup,Followup
• Report Date: 03/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3NCC986
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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