MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-04 for CLINIMACS TUBING SET TS 73105 161-01 manufactured by Miltenyi Biotec Gmbh.
[104275074]
Patient Sequence No: 1, Text Type: N, H10
[104275075]
During the integrity test run just after the ts kit was loaded onto the clinimacs machine, a small leak from one of the junctions under the liquid sensor was noted. The run was terminated upon the failed kit inspection. The lot number of the ts kit was b2398. A new ts kit of the same lot (b2398) was loaded onto the clinimacs machine, passed inspection and the selection was performed without incident. Product was not affected negatively in any way and processing continued according to relevant standard operating procedures. Miltenyi was notified via email of the kit leak.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7395234 |
| MDR Report Key | 7395234 |
| Date Received | 2018-04-04 |
| Date of Report | 2018-03-20 |
| Date of Event | 2018-03-06 |
| Report Date | 2018-03-20 |
| Date Reported to FDA | 2018-03-20 |
| Date Reported to Mfgr | 2018-03-20 |
| Date Added to Maude | 2018-04-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINIMACS TUBING SET TS |
| Generic Name | MAGNETIC CELL SELECTION SYSTEM FOR TREATMENT OF ACUTE MYELOGENOUS LEUKEMIA (AML |
| Product Code | OVG |
| Date Received | 2018-04-04 |
| Model Number | 73105 |
| Catalog Number | 161-01 |
| Lot Number | B2398 |
| Device Expiration Date | 2018-05-23 |
| Device Availability | N |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MILTENYI BIOTEC GMBH |
| Manufacturer Address | 2303 LINDBERGH ST. AUBURN CA 95602 US 95602 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-04 |