FDA Adverse Event
Malfunction
Summary report: N
PROMETRA PROGRAMMABLE PUMP
MDR report key: 3802366
·
Received February 21, 2014
Report
- Report Number
- 3006803715-2014-00004
- Event Type
- Malfunction
- Date Received
- February 21, 2014
- Report Date
- January 23, 2014
- Manufacturer
- FLOWONIX MEDICAL, INC.
- Product Code
- LKK
- PMA / PMN Number
- P080012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP REMAINS IMPLANTED IN THE PATIENT. (B)(4).
Description of Event or Problem · 1
THE PHYSICIAN REPORTED A DRUG RESERVOIR VOLUME DISCREPANCY DURING A ROUTINE REFILL VISIT. THE EXPECTED VOLUME WAS 1.2ML, BUT 20ML WAS ASPIRATED. A CATHETER ACCESS PORT (CAP) PROCEDURE WAS PERFORMED AND INDICATED THAT THE CATHETER WAS PATENT AND IN THE CORRECT LOCATION. IT WAS REPORTED THAT THE DISCREPANCY ISSUE HAS BEEN OBSERVED IN EACH OF THE PAST 3 REFILLS BUT WAS ONLY REPORTED TO FLOWONIX ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 109986 | PROMETRA PROGRAMMABLE PUMP | IMPLANTABLE INFUSION PUMP | LKK | FLOWONIX MEDICAL, INC. | 91827 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |