MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-07-01 for CLINIMACS? PLUS INSTRUMENT N/A 151-01 manufactured by Miltenyi Biotec Gmbh.
[48657463]
Patient Sequence No: 1, Text Type: N, H10
[48657464]
The customer called the miltenyi biotec (b)(4) hotline and complained about a repeated pump stalled error within a clinimacs plus instrument without any evidence. After the hotline call, the customer was able to finish the cell separation procedure. Therefore any risk for the patient could be ruled out. Process control code: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005290010-2016-00075 |
| MDR Report Key | 5765403 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-07-01 |
| Date of Report | 2016-06-30 |
| Date of Event | 2016-06-02 |
| Date Mfgr Received | 2016-06-02 |
| Date Added to Maude | 2016-07-01 |
| 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 | 2016-07-01 |
| Model Number | N/A |
| Catalog Number | 151-01 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-07-01 |