FDA Adverse Event
Malfunction
Summary report: N
NIMBUS II PLUS AMBULATORY INFUSION PUMP
MDR report key: 17706079
·
Received September 7, 2023
Report
- Report Number
- 3011581906-2023-00167
- Event Type
- Malfunction
- Date Received
- September 7, 2023
- Report Date
- October 19, 2023
- Manufacturer
- INFUTRONIX, LLC
- Product Code
- FRN
- UDI-DI
- 00017170020161
- PMA / PMN Number
- K153193
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. THIS PUMP PASSED ALL PREVIOUS TESTS. COMPLAINT DATA WAS REVIEWED, THERE ARE NO PREVIOUS COMPLAINTS ON THIS DEVICE. ANALYSIS OF THE RETURNED DEVICE IS COMPLETE. THE RESULTS ARE BELOW: THE PUMP WAS CONNECTED TO AN ADMINISTRATION SET (HS-008, LOT # 2203016) AND AN 100 ML INFUSION WAS RUN. THE VOLUME INFUSED WAS 96.60 ML. THE PROGRAMMED VOLUME WAS 100 ML. SO, THE FLOW RATE DEVIATION IS -3.4%. THE FLOW RATE ACCURACY IS WITHIN +/- 5% WHICH MEETS THE PASSING CRITERIA.THE REPORTED ISSUE IS NOT CONFIRMED.
Description of Event or Problem · 0
715032 NOT ADMINISTERING MEDS CORRECTLY.
Description of Event or Problem · 0
A CUSTOMER REPORTED THAT A PUMP WAS NOT ADMINISTERING MEDICATION CORRECTLY. MEDICATION WAS UNKNOWN. INFUSION PARAMETERS WERE UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1208396 | NIMBUS II PLUS AMBULATORY INFUSION PUMP | AMBULATORY INFUSION PUMP | FRN | INFUTRONIX, LLC | NIMBUS II PLUS | 2206213120 | 00017170020161 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |