MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-24 for HARVEST TERUMO SMP211500 manufactured by Terumo Bct.
[90952846]
Additional product code: fmf investigation: the machine was returned to terumo bct for repair and investigation. A service technician visually inspected the device and was able to duplicate the reported condition. The service technician noticed that the lid magnet was not properly aligned which caused the lid to open and the led light turns off before the lid latches giving a false indication of being closed. It was also noted that the machine runs with the lid not fully latched, however, as soon as the machine completely stops, the lid pops opens and the led light turns on. The magnet plate and window/gaskets assembly were replaced. The latch and magnet adjustment were performed per manufacturer's specification. Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[90952847]
The customer reported that a smartprep centrifuge lid latch was not locking properly and was unable to start a procedure. The device was returned for repair and evaluation. Upon evaluation of the device, the terumo bct service technician noted that the centifuge lid popped open while the rotor was still spinning. 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 | 1722028-2017-00411 |
| MDR Report Key | 6972816 |
| Date Received | 2017-10-24 |
| Date of Report | 2017-10-24 |
| Date of Event | 2017-09-29 |
| Date Mfgr Received | 2018-01-03 |
| Date Added to Maude | 2017-10-24 |
| 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 SMP2, 115V, 20/60 BW |
| Product Code | JQC |
| Date Received | 2017-10-24 |
| Model Number | SMP211500 |
| 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 | 2017-10-24 |