MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-05-05 for CLINIMACS CD34 REAGENT N/A 171-01 manufactured by Miltenyi Biotec Gmbh.
[44677094]
Miltenyi biotec (b)(4) has handed over an investigation questionnaire to the customer to obtain more details about the complained clinimacs? Cell separation. Based on the entire data and the facs plots of the positive fraction received, following results can be ascertained: the source product for the selection procedure was a fresh, mobilized leukapheresis product containing 27xl0e9 tnc and 76,8xl0e6 cd34-cells (= 0,28% cd34+). The separation was performed with one vial of clinimacs? Cd34 reagent, clinimacs? Tubing set and cd34 selection! -program. Igg was added prior labeling for blocking of unspecific binding sites. Small aggregates were observed in the original fraction positive fraction: viability was 94% cd34+ recovery was indeed 31 % purity was 94% results #: the selection procedure has been performed inside the specifications of the clinimacs? Cd34 reagent and the respective tubing set. The plt-wash was not exactly done at a 1:3 dilution. By using a lower amount of buffer, the platelet removal might not have been sufficient with potential consequence of weak labeling and loss of cd34+-cells.
Patient Sequence No: 1, Text Type: N, H10
[44677095]
The customer complained that the recovery of cd34+-cells was low (3. 3%) for a clinimacs separation procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005290010-2016-00065 |
| MDR Report Key | 5634846 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-05-05 |
| Date of Report | 2016-05-04 |
| Date of Event | 2016-03-11 |
| Date Mfgr Received | 2016-04-06 |
| Device Manufacturer Date | 2015-12-21 |
| Date Added to Maude | 2016-05-05 |
| 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 | 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 | 2016-05-05 |
| Model Number | N/A |
| Catalog Number | 171-01 |
| Lot Number | 6151218004 |
| Device Expiration Date | 2016-05-18 |
| 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 | 2016-05-05 |