MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-04-12 for CLINIMACS CD34 REAGENT N/A 171-01 manufactured by Miltenyi Biotec Gmbh.
[72657449]
Not returned to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[72657450]
The customer complained on a poor cell separation performance (purity: 44. 69%, yleld: 55. 28%) while using the clinimacs? Cd34 system in a multicenter investigator-initiated clinical trial (transplantation of autologous cd34+ cells for patients with femoral or tibial fracture nonunion). The purity was below the criteria for transplantation. The immune-magnetic labeling was done in a classic in-bag procedure. The process code is given: (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005290010-2017-00010 |
| MDR Report Key | 6487674 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-04-12 |
| Date of Report | 2017-04-11 |
| Date of Event | 2017-03-10 |
| Date Mfgr Received | 2017-03-13 |
| Device Manufacturer Date | 2017-01-06 |
| Date Added to Maude | 2017-04-12 |
| 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 | 120 BEACON ST SUITE 200 |
| Manufacturer City | SOMERVILLE MA 02143 |
| Manufacturer Country | US |
| Manufacturer Postal | 02143 |
| 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 | NO |
| 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 | 2017-04-12 |
| Model Number | N/A |
| Catalog Number | 171-01 |
| Lot Number | 6161227003 |
| Device Expiration Date | 2017-06-05 |
| 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 | 2017-04-12 |