MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-25 for HARVEST TERUMO SMP2115 manufactured by Terumo Bct.
[91086456]
Additional product code: fmf investigation: an internal report shows that the machine has been in use with no further occurrences of the problem. One year of service history was reviewed for this device with no problems identified related to the reported condition. Corrective action: an internal capa has been initiated to evaluate reports of the lid latch issues. Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[91086457]
During a conversation, the customer mentioned that the lid of the smartprep would not stay closed during a platelet rich plasma (prp) procedure. The procedure could not be completed unless the lid was held down manually. There was not a donor or patient involved at the time of the incident, therefore no patent information is reasonably known at the time of the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2017-00416 |
| MDR Report Key | 6977761 |
| Date Received | 2017-10-25 |
| Date of Report | 2017-10-25 |
| Date of Event | 2017-10-03 |
| Date Mfgr Received | 2017-11-20 |
| Date Added to Maude | 2017-10-25 |
| 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 | SMP2-115V HARVEST 20/60 |
| Product Code | JQC |
| Date Received | 2017-10-25 |
| Model Number | SMP2115 |
| 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 | 2017-10-25 |