MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-10-04 for CLINIMACS PLUS INSTRUMENT N/A 151-01 manufactured by Miltenyi Biotec Gmbh.
[56451927]
Since the affected instrument was inspected by a miltenyi biotec technician and no failure had been detected, the complained error signals remain unidentified.
Patient Sequence No: 1, Text Type: N, H10
[56451928]
The customer complained about a wrong behavior of the clinimacs plus instrument, s/n (b)(4), observed during a run of the depletion 3. 1 sequence on (b)(6) 2016. Please refer to the customer's failure report below: when they ran depletion 3. 1 tcra/ss program, they reported: installation ; ok; data entry : ok; integrity check : ok; remove the clamp from pbs/edta bag; priming; remove the clamp from cell sample bag; run : issue in the screen display : the cell flow is not displayed as usual - only the priming waste; bag is displayed. Cells have quickly ended in the non-target cell bag. Emergency stop; clamp and kit removal; instrument check : valves ok; magnet check : strong noise and strange smell; final message : "please fill liquid sensor. " as a result of these observations, the customer had to abort the process. Furthermore, the customer stated at the time point of the event, no patient was affected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005290010-2016-00092 |
| MDR Report Key | 5998045 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-10-04 |
| Date of Report | 2016-10-04 |
| Date of Event | 2016-09-04 |
| Date Mfgr Received | 2016-09-05 |
| Date Added to Maude | 2016-10-04 |
| 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 | 2016-10-04 |
| Model Number | N/A |
| Catalog Number | 151-01 |
| 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 | 2016-10-04 |