MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-12-08 for HARVEST TERUMO 51470 manufactured by Terumo Bct.
[94855641]
Additional product code: fmf. Investigation: the machine was returned to terumo bct for repair and investigation. A service technician visually inspected the device and noted that the lid open detection circuit functions properly and stops the rotor when the lid is open. No other functional issues were found. Simulated use testing was done by performing three procedural cycles and it was observed that the motor spun at the correct rpm and the decant ring activated properly. The service technician observed that there were several concentric scratches on the window which indicated a possible misload of the disposable set and/or counter weights and the motor was found to be 'noisy'. The motor, scratched window and gasket were replaced, the lid latch and magnet assembly were re-adjusted. An electrical safety test hp/lc/gb (high potential/leakage current/ground bond) and a functional check out were successfully performed. The device serial number history report indicates no further related issues have been reported for this device. One year of service history was reviewed for this device with no problems identified related to the reported condition. Root cause: the root cause of this failure was a mis-adjusted lid latch. Corrective action: an internal capa has been initiated to evaluate the reports of the lid latch issues.
Patient Sequence No: 1, Text Type: N, H10
[94855642]
The customer initially reported that a smartprep machine was not decanting properly. The device was returned for repair and evaluation. Upon evaluation of the device, the terumo bct service technician noted that the unit will run without the lid being completely latched. There was not a donor or patient involved at the time of the incident, therefore no patient information is reasonably known at the time of the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2017-00475 |
| MDR Report Key | 7101972 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-12-08 |
| Date of Report | 2017-12-08 |
| Date of Event | 2017-11-16 |
| Date Mfgr Received | 2017-12-21 |
| Device Manufacturer Date | 2016-09-16 |
| Date Added to Maude | 2017-12-08 |
| 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 | STEVE KERN |
| Manufacturer Street | 10810 W. COLLINS AVE |
| Manufacturer City | LAKEWOOD CO |
| Manufacturer Phone | 3032392246 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HARVEST TERUMO |
| Generic Name | SMARTPREP 2-115V |
| Product Code | JQC |
| Date Received | 2017-12-08 |
| Returned To Mfg | 2017-11-22 |
| Model Number | 51470 |
| ID Number | 05020583514706 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-12-08 |