MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-04-06 for CLINIMACS PLUS INSTRUMENT 151-01 manufactured by Miltenyi Biotec Gmbh.
[42034408]
The customer has been contacted several times by miltenyi biotec (b)(4) in order to retrieve further information for complaint investigation. Miltenyi will follow up on this mdr once they receive the information.
Patient Sequence No: 1, Text Type: N, H10
[42034409]
The customer described poor cd34 cell viability (6%) after a cell selection using the clinimacs cd34 cell selection system. The cells were not transplanted. The customer was able to separate cd34+ cells within a second separation and treated the patient accordingly. There was no risk to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005290010-2016-00062 |
| MDR Report Key | 5552181 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-04-06 |
| Date of Report | 2016-04-06 |
| Date of Event | 2016-03-07 |
| Device Manufacturer Date | 2001-07-01 |
| Date Added to Maude | 2016-04-06 |
| 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 |
| 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 PLUS INSTRUMENT |
| Generic Name | CLINIMACS PLUS INSTRUMENT |
| Product Code | OVG |
| Date Received | 2016-04-06 |
| Catalog Number | 151-01 |
| 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 | 2016-04-06 |