MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,health professional report with the FDA on 2015-04-10 for SCD IIB STERILE TUBING WELDER 3NCC986 manufactured by Terumo Bct.
[5678185]
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.
Patient Sequence No: 1, Text Type: D, B5
[13197947]
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.
Patient Sequence No: 1, Text Type: N, H10
[13332543]
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.
Patient Sequence No: 1, Text Type: N, H10
[19231666]
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.
Patient Sequence No: 1, Text Type: N, H10
[50864959]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1722028-2015-00135 |
| MDR Report Key | 4682344 |
| Report Source | 05,HEALTH PROFESSIONAL |
| Date Received | 2015-04-10 |
| Date of Report | 2015-03-17 |
| Date of Event | 2015-02-18 |
| Date Mfgr Received | 2016-07-29 |
| Date Added to Maude | 2015-04-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | GLENDA O'NEILL |
| Manufacturer Street | 10811 W. COLLINS AVE |
| Manufacturer City | LAKEWOOD CO 80215 |
| Manufacturer Country | US |
| Manufacturer Postal | 80215 |
| Manufacturer Phone | 3032314051 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCD IIB STERILE TUBING WELDER |
| Generic Name | SCD IIB STERILE TUBING WELDER |
| Product Code | KSB |
| Date Received | 2015-04-10 |
| Model Number | 3NCC986 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO BCT |
| Manufacturer Address | LAKEWOOD CO 80215 US 80215 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-04-10 |