MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-05 for HARVEST TERUMO SMP211501 manufactured by Terumo Bct.
[95068616]
Additional product code: fmf. Investigation: the smartprep device was returned to terumo bct for repair and evaluation. The service technician was able to duplicate the reported condition. The service technician noted that the lid was hard to close completely due to the latch being out of adjustment and pressure must be applied down since it was very hard to close completely due to the latch being out of adjustment. It was also noted that the unit will run without the lid being completely latched but as soon as the lid is lifted slightly, the magnet will disengage the reed switch and the unit stops. No other functional issues were found. A simulated use testing were performed by performing three procedural cycles and it was observed that the motor spun at the correct rpm and the decantring activated properly. Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[95068617]
The customer reported that the lid latch of the smartprep centrifuge would not stay closed. There was not a donor or patient involved at the time of the procedure, therefore no patient information is reasonably known at the time of the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2017-00462 |
| MDR Report Key | 7082776 |
| Date Received | 2017-12-05 |
| Date of Report | 2017-12-05 |
| Date of Event | 2017-11-10 |
| Date Mfgr Received | 2018-04-12 |
| Date Added to Maude | 2017-12-05 |
| 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 80215 |
| Manufacturer Country | US |
| Manufacturer Postal | 80215 |
| Manufacturer Phone | 3032392246 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HARVEST TERUMO |
| Generic Name | HARVEST SMARTPREP2, 115V |
| Product Code | JQC |
| Date Received | 2017-12-05 |
| Model Number | SMP211501 |
| 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 | 2017-12-05 |