MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-05-24 for CLINIMACS PLUS INSTRUMENT N/A 151-01 manufactured by Miltenyi Biotec Gmbh.
[75920082]
Miltenyi biotec inc. Initiated a maintenance service on 16th may 2017 which included testing the pump unit movement and tolerances. The results were laid dov/n in service report id #(b)(4). There were no deficiencies found at the time of the service. Furthermore, the cam team of miltenyi biotec inc. Also noted that they provided the customer with an extra tubing set, buffer, reagent and frozen cell sample. As a result, the customer was able to run the mock sample without any errors. Therefore, the complained failure couldn't be confirmed by miltenyi biotec.
Patient Sequence No: 1, Text Type: N, H10
[75920083]
During elution step of a clinimacs? Cd34 enrichment, there was a pump stall error notification on the screen and the product was not expelled into the collection bag. The customer wanted someone to look at the process file and investigate whether there is a risk of this being a re-occurring problem. Date of event is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005290010-2017-00019 |
| MDR Report Key | 6589893 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-05-24 |
| Date of Report | 2017-05-24 |
| Date Mfgr Received | 2017-04-25 |
| Device Manufacturer Date | 2016-11-11 |
| Date Added to Maude | 2017-05-24 |
| 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 | 120 BEACON ST SUITE 200 |
| Manufacturer City | SOMERVILLE MA 02143 |
| Manufacturer Country | US |
| Manufacturer Postal | 02143 |
| 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 | 2017-05-24 |
| Model Number | N/A |
| Catalog Number | 151-01 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-05-24 |