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.
[91074154]
Additional product code: fmf investigation: the smartprep device was returned to terumo bct for repair and evaluation. The service technician was able to duplicate the reported condition. A simulated use test was performed by performing four full procedural cycles with no issues noted. At the start of the fifth cycle, the service technician noticed that the decant solenoids activated the lid solenoid causing the lid to open. However, it did not open enough to stop the smartprep device from running. After slightly lifting the lid, the reed switch detected the open lid and shut down the unit. The main control board was replaced to address the issue. The smartprep display board, display panel, ribbon cable, and membrane switch were replaced for compatibility with the new control board. The vibration isolation, latch plunger springs, feet, window, gasket and magnet plate were proactive replacements. The latch was adjusted to meet the 25lbs. Latching requirement. All functional tests were successfully performed with no issues after the repair. 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 iv poled ropping down suddenly. Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[91074155]
The customer reported that after the first centrifuge spin, the smartprep device stops the centrifuge and unlocks the lid latch. 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 | 1722028-2017-00417 |
| MDR Report Key | 6978001 |
| Date Received | 2017-10-25 |
| Date of Report | 2017-10-25 |
| Date of Event | 2017-09-12 |
| Date Mfgr Received | 2017-12-14 |
| 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 |