MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-07-06 for HARVEST TERUMO SMP211500 manufactured by Terumo Bct.
[79758137]
Additional product code: fmf investigation: a machine checkout was performed by a terumo bct sevice technician and was able to duplicate the reported condition. Upon visual inspection, it was noted that the lid latch magnet was found out of alignment and the magnet was unable to activate the reed switch before the lid was completely latched. The service technician replaced and adjusted the magnet plate per manufacturer's specification. Three operational runs was succesffully performed on the device. Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[79758138]
The customer reported that a smartprep centrifuge lid latch was not functioning properly and the device was returned for repair and evaluation. Upon evaluation of the device, the terumobct 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 | 1722028-2017-00290 |
| MDR Report Key | 6689952 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-07-06 |
| Date of Report | 2017-07-06 |
| Date of Event | 2017-06-22 |
| Date Mfgr Received | 2017-10-19 |
| Date Added to Maude | 2017-07-06 |
| 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 | SMARTPREP 2-115V 20/60 BW |
| Product Code | JQC |
| Date Received | 2017-07-06 |
| 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 | 2017-07-06 |