FDA Adverse Event
Malfunction
Summary report: N
INFUSOMAT SPACE - US VERSION
MDR report key: 4003308
·
Received July 31, 2014
Report
- Report Number
- 9610825-2014-00296
- Event Type
- Malfunction
- Date Received
- July 31, 2014
- Report Date
- July 21, 2014
- Manufacturer
- B. BRAUN MELSUNGEN AG
- Product Code
- FRN
- PMA / PMN Number
- K062700
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4). THE ACTUAL DEVICE HAS NOT BEEN RECEIVED YET AND THE INVESTIGATION IS ON GOING AT THIS TIME. A FOLLOW UP REPORT WILL BE PROVIDED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE. (B)(4).
Description of Event or Problem · 1
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS UNDER INFUSION, CUSTOMER VERBALIZED THAT HE DOES NOT KNOW WHAT MEDICATION OR TUBING USED, NO SETTINGS VERBALIZED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 448981 | INFUSOMAT SPACE - US VERSION | INFUSION PUMP | FRN | B. BRAUN MELSUNGEN AG | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |