MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-07-21 for HARVEST TERUMO SMP211500 manufactured by Terumo Bct.
[80927177]
Additional product code: fmf. Investigation: the machine was returned to terumo bct for repair and investigation. A service technician visually inspected the device and confirmed that the lid latch was out of adjustment. A new latch and magnet plate was installed and the lid latch was realigned. A simulated use test was performed and confirmed that the lid stayed closed through three full cycles. The machine is functioning within specification. Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[80927178]
The customer reported that during a procedure, the lid of a smart prep 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 | 1722028-2017-00298 |
| MDR Report Key | 6732163 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-07-21 |
| Date of Report | 2017-07-21 |
| Date of Event | 2017-06-28 |
| Date Mfgr Received | 2017-10-19 |
| Date Added to Maude | 2017-07-21 |
| 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 | 2017-07-21 |
| 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 | 2017-07-21 |