FDA Adverse Event
Malfunction
Summary report: N
CLINIMACS CD34 REAGENT SYSTEM
MDR report key: 5671276
·
Received May 23, 2016
Report
- Report Number
- 3005290010-2016-00069
- Event Type
- Malfunction
- Date Received
- May 23, 2016
- Date of Event
- April 26, 2016
- Report Date
- May 20, 2016
- Manufacturer
- MILTENYI BIOTEC GMBH
- Product Code
- OVG
- UDI-DI
- 04049934004841
- PMA / PMN Number
- BH110018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED TO THE MANFUACTURER.
Description of Event or Problem · 1
A CLINIMACS® CD34 SELECTION HAS BEEN PERFORMED BY THE CUSTOMER. IN TOTAL 76.4XL0E9 WBC (WHITE BLOOD CELLS) INCLUDING 1.8XL0E9 CD34 CELLS HAVE BEEN PROCESSED USING ONE VIAL OF CLINIMACS® CD34 REAGENT AND THE ENRICHMENT PROGRAM SELECTION 1 APPLYING THE CLINIMACS® TUBING SET. THE CD34 YIELD AFTER THE SELECTION WAS LOW. THE CUSTOMER STATED THAT THEY USED ANOTHER TUBING SET TO SEPARATE THE CD34+ CELLS FROM THE NEGATIVE FRACTION BAG. THEREFORE ANY RISK FOR THE PATIENT COULD BE RULED OUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 329063 | CLINIMACS CD34 REAGENT SYSTEM | CLINIMACS TUBING SET LS | OVG | MILTENYI BIOTEC GMBH | N/A | NOT KNOWN | 04049934004841 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |