MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-03-29 for CLINIMACS TUBING SET N/A 161-01 manufactured by Miltenyi Biotec Gmbh.
[71208264]
Device not returned to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[71208265]
The customer complained on (b)(6) 2017 on a clinimacs? Tubing set which was ieaking during priming step at che lower portion of the 4-way connection on the outside tube that runs along the left side of the clinimacs? Plus instrument. No integrity test was performed as it had not come no that point yet. The customer stated further that the cellular material of the patient was still available. Therefore, any risk for the patient could be ruled out. They used a spare tubing set to perform the cell separation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005290010-2017-00006 |
| MDR Report Key | 6443238 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-03-29 |
| Date of Report | 2017-03-24 |
| Date of Event | 2017-02-21 |
| Date Mfgr Received | 2017-02-28 |
| Device Manufacturer Date | 2015-12-04 |
| Date Added to Maude | 2017-03-29 |
| 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 | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINIMACS TUBING SET |
| Generic Name | CLINIMACS TUBING SET |
| Product Code | OVG |
| Date Received | 2017-03-29 |
| Model Number | N/A |
| Catalog Number | 161-01 |
| Lot Number | B2398 |
| Device Expiration Date | 2018-05-23 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2017-03-29 |