MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-08-25 for CLINIMACS CD34 REAGENT NOT KNOWN 171-01 manufactured by Miltenyi Biotec Gmbh.
[53038976]
Patient Sequence No: 1, Text Type: N, H10
[53038977]
A clinimacs cd34 selection has been performed by the customer. The customer complained that the enriched cd34+ stem cells were antigen positive for cd56 after the cell enrichment. The patient received the cellular transplant. Therefore any risk for the patient could be ruled out. The forthcoming cytopenia was not due to any of the components of the clinimacs cd34 system as stated by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005290010-2016-00085 |
| MDR Report Key | 5904665 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-08-25 |
| Date of Report | 2016-08-22 |
| Date of Event | 2016-07-05 |
| Date Mfgr Received | 2016-07-24 |
| Device Manufacturer Date | 2016-06-06 |
| Date Added to Maude | 2016-08-25 |
| 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 | 2016-08-25 |
| Model Number | NOT KNOWN |
| Catalog Number | 171-01 |
| Lot Number | 6160602011 |
| Device Expiration Date | 2016-11-03 |
| 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 | 2016-08-25 |