FDA Adverse Event
Other
Summary report: N
HOMEPUMP C-SERIES
MDR report key: 1971918
·
Received January 24, 2011
Report
- Report Number
- 2026095-2011-00010
- Event Type
- Other
- Date Received
- January 24, 2011
- Date of Event
- December 29, 2010
- Report Date
- January 5, 2011
- Manufacturer
- I-FLOW CORP.
- Product Code
- MEB
- PMA / PMN Number
- K052117
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SAMPLE HAS NOT YET BEEN RECEIVED, BUT WAS REPORTED TO BE AVAILABLE. THE SAMPLE WILL BE EVALUATED WHEN RECEIVED AND F/U REPORT WILL BE FILED.
Description of Event or Problem · 1
PT NOTICED THAT PUMP INFUSED TOO FAST; INFUSED 25 HOURS INSTEAD OF 48. NO ADVERSE EVENT OCCURRED. ASKED BUT NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOMEPUMP C-SERIES | ELASTOMERIC PUMP | MEB | I-FLOW CORP. | C100020 | 972638 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |