MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2015-08-13 for MULTIPLEX CONROLLER 3610 manufactured by Dfine Inc..
[24715231]
The product has not been received within our facility for evaluation. Upon receipt, final evaluation will be conducted and supplemental report will be filed accordingly.
Patient Sequence No: 1, Text Type: N, H10
[24715232]
Per received report: during 3 level va case t6, 8 and 9, and while delivering cement to the last level, the multiplex controller stopped showed cement delivery on screen. On flouro, the cement was not seen exiting the delivery cannula (dc) which was in the middle 1/3 of the vertebral body. The territory sales manager (tsm) immediately looked for resistance bars on the multiplex which would demonstrate that the situation could have been up against a hard bone and resistance sensed. The physician was asked to stop delivery, which he already did. The cannula was then pulled back a few millimeters and attempted delivery. Same thing occurred with no bars present, and the physician hit stop. He pulled back a few millimeters and a significant amount of cement entered the vertebral body from dc, shot backwards very quickly and appeared to enter the spinal canal. Patient was asymptomatic for any neuro deficit post op. The cement syringe was examined and noted less than 1 cc remaining. The equipment failed to notify the user via resistance bas that there was na issue with normal delivery of cement. Is also failed to notify user that 1 cc was remaining via resistance bar build and audible tone change. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[29983724]
The customer reported issue could not be confirmed. Upon inspection on the multiplex controller performed in-house, all visual, electrical and functional testing passed and all required specifications were met. There were no noted issues, red light flashing, awkward beep, graphic display or any significant failure was noted during the testing process that would indicate any discrepancies as indicated in the initial report. The additional testing performed via activation element (ae) tip occlusion revealed that the unit did not fail to alert user as it encountered dense material by the emergence of resistance bars on the front display of the unit combined with an audible tone. In addition, a change in the audible tone as the unit reached <1cc remaining in the syringe was heard, contrary to the initial report that equipment failed significantly. Furthermore, the emergence of the resistance bars on the screen and the change in the audible tone as the cement decreased to <1cc remaining may not have been observed or heard by the user during the procedure. Hence these safety features were achieved as designed. The unit performed as intended and is functionally fit for use. Although there does not appear to be any indication of a product quality deficiency, a definitive cause for the reported issue cannot be determined. All units are 100% visually inspected and tested for its functionality during the manufacturing process and only passing units are moved to the next process. Additionally, the unit undergoes through series of electrical evaluations to verify the multiplex controller's integrity.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006396387-2015-00011 |
| MDR Report Key | 5008470 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2015-08-13 |
| Date of Report | 2015-07-16 |
| Date of Event | 2015-07-16 |
| Date Mfgr Received | 2015-07-09 |
| Device Manufacturer Date | 2013-02-22 |
| Date Added to Maude | 2015-08-17 |
| 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 | DAN BALBIERZ |
| Manufacturer Street | 3047 ORCHARD PARKWAY |
| Manufacturer City | SAN JOSE CA 951340000 |
| Manufacturer Country | US |
| Manufacturer Postal | 951340000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTIPLEX CONROLLER |
| Generic Name | MULTIPLEX CONTROLLER |
| Product Code | GFI |
| Date Received | 2015-08-13 |
| Model Number | NA |
| Catalog Number | 3610 |
| Lot Number | DMC-500 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DFINE INC. |
| Manufacturer Address | 3047 ORCHARD PARKWAY SAN JOSE CA 95134 US 95134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-13 |