MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-10 for TRIMA ACCEL 81000 manufactured by Terumo Bct.
[185104207]
Investigation: a terumo bct service technician checked out the machine at the customer site and was able to confirm the reported condition. Upon inspection it was found that the button was always touching the stopper. The button was adjusted and the machine was returned to service. The device serial number history report indicates no further related issues have been reported for this device. One year of service history was reviewed for this device with no other problems identified related to the reported condition. Correction: the iv pole clamp was installed on this device on (b)(6) 2018 per fa 30. Corrective action: an internal capa has been initiated to evaluate reports of the iv pole dropping down suddenly. Implementation of the addition of a collar for the currently field installed devices will be completed to address this issue. Root cause: the root cause of this failure was a misalignment of the release button.
Patient Sequence No: 1, Text Type: N, H10
[185104208]
The customer reported that the iv pole on the trima equipment unexpectedly lowers down. No injury was reported for this incident and no patient was connected at the time the iv pole was sliding down, therefore no patient information is reasonably known.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2020-00098 |
| MDR Report Key | 9812779 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2015-09-09 |
| Date Added to Maude | 2020-03-10 |
| 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 | SCOT HILDEN |
| Manufacturer Street | 10810 W. COLLINS AVE |
| Manufacturer City | LAKEWOOD CO 80215 |
| Manufacturer Country | US |
| Manufacturer Postal | 80215 |
| Manufacturer Phone | 3032314970 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIMA ACCEL |
| Generic Name | TRIMA MACHINE FINAL ASSY |
| Product Code | GKT |
| Date Received | 2020-03-10 |
| Model Number | 81000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2020-03-10 |