MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-09-22 for CLINIMACS CD34 REAGENT N/A 171-01 manufactured by Miltenyi Biotec Gmbh.
[55437772]
Patient Sequence No: 1, Text Type: N, H10
[55437773]
On (b)(6) 2016 a clinimacs cd34 selection was performed by the customer. In total 9. 5xl0e9 wbc (white blood cells) containing 7. 2xl0e7 cd34+ cells were processed using one vial of clinimacs cd34 reagent and the enrichment program cd34 selection 1 applying the clinimacs tubing set. The cd34+ yield as well as the purity of the target cells in the target cell fraction after the selection have been reported to be very low (yield: 4. 4%; purity: 14. 6%).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005290010-2016-00089 |
| MDR Report Key | 5970535 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-09-22 |
| Date of Report | 2016-09-21 |
| Date of Event | 2016-08-23 |
| Date Mfgr Received | 2016-08-26 |
| Device Manufacturer Date | 2016-05-09 |
| Date Added to Maude | 2016-09-22 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS NANCY JOHANSEN |
| Manufacturer Street | 85 HAMILTON ST |
| Manufacturer City | CAMBRIDGE MA 02139 |
| Manufacturer Country | US |
| Manufacturer Postal | 02139 |
| Manufacturer Phone | 6172180062 |
| Manufacturer G1 | MILTENYI BIOTEC GMBH |
| Manufacturer Street | FRIEDRICH-EBERT-STRASSE 68 |
| Manufacturer City | BERGISCH GLADBACH, 51429 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 51429 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINIMACS CD34 REAGENT |
| Generic Name | CLINIMACS CD34 REAGENT |
| Product Code | OVG |
| Date Received | 2016-09-22 |
| Model Number | N/A |
| Catalog Number | 171-01 |
| Lot Number | 6160506001 |
| Device Expiration Date | 2016-10-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MILTENYI BIOTEC GMBH |
| Manufacturer Address | FRIEDRICH-EBERT-STRASSE 68 BERGISCH GLADBACH, 51429 GM 51429 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-22 |