FDA Adverse Event
Malfunction
Summary report: N
NIMBUS II PLUS AMBULATORY INFUSION PUMP
MDR report key: 15855330
·
Received November 23, 2022
Report
- Report Number
- 3011581906-2022-00228
- Event Type
- Malfunction
- Date Received
- November 23, 2022
- Date of Event
- November 7, 2022
- Report Date
- November 23, 2022
- Manufacturer
- INFUTRONIX, LLC.
- Product Code
- FRN
- UDI-DI
- 00817170020161
- PMA / PMN Number
- K153193
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INFUTRONIX IS WAITING FOR THE AFFECTED DEVICE TO BE RETURNED.
Description of Event or Problem · 0
INFUTRONIX LLC RECEIVED A COMPLAINT FROM A PATIENT, REPORTING "A PUMP ALARMING PUMP UNATTENDED". PUMP DID NOT ALARM. PATIENT WAS ABLE TO GET THE PUMP WORKING AGAIN, BUT THEN IT WAS OBSERVED THAT THE PUMP WAS UNDERDELIVERING. PATIENT WAS INSTRUCTED TO CALL THEIR FACILITY AND MAKE ARRANGEMENTS TO SWAP OUT THE PUMP. DEVICE OPERATOR WAS A PATIENT. MEDICATION BEING INFUSED WAS UNKNOWN. NO PATIENT INJURY REPORTED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS ZYNO ELECTRIC & MACHINERY LTD, SHANGHAI.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309062 | NIMBUS II PLUS AMBULATORY INFUSION PUMP | AMBULATORY INFUSION PUMP | FRN | INFUTRONIX, LLC. | NIMBUS II PLUS | 2111081200 | 00817170020161 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Male |