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 2016-05-23 for CLINIMACS CD34 REAGENT SYSTEM N/A manufactured by Miltenyi Biotec Gmbh.
[45702156]
Device not returned to the manfuacturer.
Patient Sequence No: 1, Text Type: N, H10
[45702157]
A clinimacs? Cd34 selection has been performed by the customer. In total 76. 4xl0e9 wbc (white blood cells) including 1. 8xl0e9 cd34 cells have been processed using one vial of clinimacs? Cd34 reagent and the enrichment program selection 1 applying the clinimacs? Tubing set. The cd34 yield after the selection was low. The customer stated that they used another tubing set to separate the cd34+ cells from the negative fraction bag. Therefore any risk for the patient could be ruled out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005290010-2016-00069 |
| MDR Report Key | 5671276 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-05-23 |
| Date of Report | 2016-05-20 |
| Date of Event | 2016-04-26 |
| Date Mfgr Received | 2016-04-06 |
| Device Manufacturer Date | 2015-12-21 |
| Date Added to Maude | 2016-05-23 |
| 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 SYSTEM |
| Generic Name | CLINIMACS TUBING SET LS |
| Product Code | OVG |
| Date Received | 2016-05-23 |
| Model Number | N/A |
| Catalog Number | N/A |
| Lot Number | NOT KNOWN |
| 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 | 2016-05-23 |