MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-05-05 for CLINIMACS CD34 REAGENT N/A 171-01 manufactured by Miltenyi Biotec Gmbh.
[44564823]
Miltenyi biotec (b)(4) has handed over an investigation questionnaire to the customer to obtain more details about the complained clinimacs? Separation. Moreover, flow cytometry data has been requested. The customer sent in a filled investigation questionnaire and a flow cytometry analysis sheet from the target fraction. Based on the given information following statement can be made: the source product for the selection procedura was a fresh, mobilized leukapheresis product, containing 35xl0e9 tnc (total nucleated cells) and 364. 8xl0e6 cd34 +-cells (= 1. 04% cd34+). The separation was performed with one vial of clinimacs? Cd34 reagent, and the respective clinimacs? Tubing set. The reagent was used within the specification using the enrichment program cd34 selection 1. The process code does not indicate any malfunction of the clinimacs? Plus instrument. Igg was added prior labeling for blocking of unspecific binding sites. Only 12. 1x106 out the initial 365x106 cd34-t- cells were found in the target cell bag. The resulting target cell recovery is therefore 3. 3%. No flow cytometry data available for negative fraction and/or initial cell product. The flow analysis data sheet from the target cell fraction does not indicate any discrepancies in the gating. The purity for cd34+ stem cells was 88. 4%. Small aggregates were observed in the original fraction. Based on the data provided by the customer it is impossible to make any assessment regarding the possible root cause. The reagent was used within the specification. No major deviations from the recommended protocol have been identified. No malfunction of the clinimacs? Plus instrument has been identified by the process code. But, it could not be ruled out whether low recovery was caused by: unfavorable composition of the initial cell product (cell aggregates were observed).
Patient Sequence No: 1, Text Type: N, H10
[44564824]
The customer complained that the recovery of cd34+- cells was low (3. 3%) for a clinimacs? Separation procedura.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005290010-2016-00066 |
| MDR Report Key | 5635406 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-05-05 |
| Date of Report | 2016-05-04 |
| Date of Event | 2016-03-24 |
| 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 |