FDA Adverse Event
Malfunction
Summary report: N
CLINIMACS®PLUS INSTRUMENT
MDR report key: 5230472
·
Received November 17, 2015
Report
- Report Number
- 3005290010-2015-00019
- Event Type
- Malfunction
- Date Received
- November 17, 2015
- Date of Event
- September 23, 2015
- Report Date
- November 4, 2015
- Manufacturer
- MILTENYI BIOTEC GMBH
- Product Code
- OVG
- UDI-DI
- 04049934004636
- PMA / PMN Number
- BH1100188
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE PROCESS CODE ON THE CLINIMACS PLUS INSTRUMENT INDICATED THAT THE SAMPLE LOADING HAD BEEN STOPPED BY REGULAR TIME-OUT AFTER 1080 SEC (330 ML)). THE PROCESS CODE DOES NOT INDICATE ANY MALFUNCTION DURING THE CELL SELECTION PROCESS. THE CUSTOMER IS WORKING AT THE UPPER EDGE OF THE SYSTEM SPECIFICATIONS WITH REGARD TO TOTAL CELLS AND IS THEREFORE ASKED TO SLIGHTLY INCREASE THE LOADING VOLUME. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER CALLED TECHNICAL HOTLINE ON (B)(6) 2015 AND REPORTED AN INCOMPLETE SAMPLING LOAD DURING CLINIMACS CD34 SELECTION CLINIMACS PROCESS CODE: (B)(4). BASED ON THE INFORMATION PROVIDED NOT HARM WAS CAUSED TO PATIENT. (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 761932 | CLINIMACS®PLUS INSTRUMENT | CLINIMACS® PLUS INTSTRUMENT | OVG | MILTENYI BIOTEC GMBH | N/A | 04049934004636 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |