MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-22 for HARVEST TERUMO 51470 manufactured by Terumo Bct.
[88239057]
Additional product codes: fmf. Investigation: the smartprep machine was returned to terumo bct for repair. A service technician checked out the machine and was able to duplicate the reported condition. The technician noted that the finishing washer for the lid strike screw was broken, causing the strike to be loose and the lid not able to latch properly. The finishing washer was replaced and 3 complete test cycles were performed with no issues were found. Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[88239058]
The customer reported that while using the smartprep device, the balance weight inside shattered and the lid would not stay shut while the machine continued running. The operator proceeded to hold the lid latch down on the machine to complete the procedure. 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
[119220009]
Investigation: one year of service history was reviewed for this device with no problems identified related to the reported condition. An internal report indicates no further related issues have been reported for this device. Corrective action: an internal capa has been initiated to evaluate reports of lit latch failures. Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1722028-2017-00378 |
| MDR Report Key | 6888701 |
| Date Received | 2017-09-22 |
| Date of Report | 2017-09-22 |
| Date of Event | 2017-04-19 |
| Date Mfgr Received | 2018-01-05 |
| Device Manufacturer Date | 2016-01-08 |
| Date Added to Maude | 2017-09-22 |
| 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 |
| Product Code | JQC |
| Date Received | 2017-09-22 |
| Model Number | 51470 |
| ID Number | 05020583514706 |
| 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 | 2017-09-22 |