MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-10-05 for CLINIMACS PLUS INSTRUMENT N/A 151-01 manufactured by Miltenyi Biotec Gmbh.
[56553192]
The customer provided photographs of the clinimacs? Plus instrument with the clinimacs depletion tubing set in order to demonstrate the unusually high volumes of both the target cell bag and the waste bag. Furthermore the process code (b)(64) was also sent to miltenyi biotec (b)(4) for further investigation as well as the analysis of the cellular material prior and after cell separation. Based on the data provided it can be stated that: the process code did not provide any deviations within the complained cell processing procedure. The photographic inspection did also not provide any irregularities. The investigation of the analysis data of the cellular material separated did not demonstrate abnormal results. Therefore it can be assumed that the failure resulted from a malfunction of the clinimacs? Plus instrument itself. It can be speculated that it might be a defect of a pinch valve. A concrete root cause couldn't be identified. No obvious deviations were found from the data inspection. Therefore, the instrument service of the distributor (b)(4) is asked to send a service technician to the customer to provide the outstanding instrument check and to send the outstanding information also to miltenyi biotec (b)(4), instrument service and complaint handling department.
Patient Sequence No: 1, Text Type: N, H10
[56553193]
The customer informed their distributor (b)(4), as well as the miltenyi biotec hotline and complained about unusually high volumes of both the target cell bag and the waste bag within a tcra/b depletion sequence using a clinimacs? Plus instrument. The distributor (b)(4) stated further that the customer did concentrate the cellular material by centrifugation and therefore, it could be assumed indirectly that the patient was treated thereafter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005290010-2016-00093 |
| MDR Report Key | 5999824 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-10-05 |
| Date of Report | 2016-10-04 |
| Date of Event | 2016-09-06 |
| Date Mfgr Received | 2016-09-06 |
| Date Added to Maude | 2016-10-05 |
| 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 | IN |
| 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 | 2016-10-05 |
| Model Number | N/A |
| Catalog Number | 151-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2016-10-05 |