MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-08-25 for CLINIMACS TUBING SET LS 162-01 manufactured by Miltenyi Biotec Gmbh.
[52949497]
Patient Sequence No: 1, Text Type: N, H10
[52949498]
The customer reported that they had a leakage at the connection between the connection of the priming waste bag and the tubing of one clinimacs tubing set ls. They observed the leakage during the cell separation run. The customer furthermore pointed out that they could finish the process and that they will test the cells for sterility prior to transplantation. As a consequence the patient was not harmed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005290010-2016-00081 |
| MDR Report Key | 5903147 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-08-25 |
| Date of Report | 2016-08-16 |
| Date of Event | 2016-07-13 |
| Date Mfgr Received | 2016-07-18 |
| Device Manufacturer Date | 2015-09-23 |
| Date Added to Maude | 2016-08-25 |
| 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 | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINIMACS TUBING SET LS |
| Generic Name | CLINIMACS TUBING SET LS |
| Product Code | OVG |
| Date Received | 2016-08-25 |
| Catalog Number | 162-01 |
| Lot Number | B2223 |
| Device Expiration Date | 2017-04-07 |
| 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 | 2016-08-25 |