FDA Adverse Event
Malfunction
Summary report: N
CLINIMACS TUBING SET
MDR report key: 6443238
·
Received March 29, 2017
Report
- Report Number
- 3005290010-2017-00006
- Event Type
- Malfunction
- Date Received
- March 29, 2017
- Date of Event
- February 21, 2017
- Report Date
- March 24, 2017
- Manufacturer
- MILTENYI BIOTEC GMBH
- Product Code
- OVG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED TO THE MANUFACTURER.
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 226343 | CLINIMACS TUBING SET | CLINIMACS TUBING SET | OVG | MILTENYI BIOTEC GMBH | N/A | B2398 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |