MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-28 for CLINIMACS 151-01 manufactured by Miltenyi Biotec.
[41238107]
Patient Sequence No: 1, Text Type: N, H10
[41238108]
During a cd34 cell selection on the clinimacs instrument, the process ended before all of the product had been selected. It is unknown why the process stopped, possibly due to a clot, air bubble, or device failure. No clots or air bubbles were observed, so it is possible that there is an instrument failure. Manufacturer response for clinimacs instrument, clinimacs (per site reporter): the manufacturer was contacted about this issue. No response has been received yet.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5528825 |
| MDR Report Key | 5528825 |
| Date Received | 2016-03-28 |
| Date of Report | 2016-03-04 |
| Date of Event | 2016-02-19 |
| Report Date | 2016-03-01 |
| Date Reported to FDA | 2016-03-01 |
| Date Reported to Mfgr | 2016-03-01 |
| Date Added to Maude | 2016-03-28 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINIMACS |
| Generic Name | MAGNETIC CELL SELECTION SYSTEM FOR CD34+ CELLS FROM HPC-APHERESIS USED IN TREAT |
| Product Code | OVQ |
| Date Received | 2016-03-28 |
| Model Number | 151-01 |
| Device Availability | Y |
| Device Age | 6 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MILTENYI BIOTEC |
| Manufacturer Address | 85 HAMILTON STREET CAMBRIDGE MA 02139 US 02139 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-28 |