FDA Adverse Event
Malfunction
Summary report: N
ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP
MDR report key: 11159313
·
Received January 13, 2021
Report
- Report Number
- 3011581906-2020-00111
- Event Type
- Malfunction
- Date Received
- January 13, 2021
- Date of Event
- July 29, 2020
- Report Date
- January 11, 2021
- Manufacturer
- INFUTRONIX, LLC
- Product Code
- FPA
- UDI-DI
- 00817170020048
- PMA / PMN Number
- K153193
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
ON (B)(6) /2020, INFUTRONIX CONFIRMED WITH THE DISTRIBUTOR THAT THE AFFECTED DEVICE WAS NEVER RETURNED FOR EVALUATION AND THEREFORE NO ROOT CAUSE COULD BE ESTABLISHED. THIS MDR IS A RESULT OF COMPLAINT REMEDIATION EFFORT.
Description of Event or Problem · 1
ON (B)(6) 2020, A DISTRIBUTOR OF INFUTRONIX REPORTED AN ISSUE ON BEHALF OF AN END USER: "PATIENT REPORTED THAT THEIR CATHETER DISCONNECTED FROM THE TUBING." DEVICE OPERATOR WAS A PATIENT. MEDICATION INFUSED WAS UNKNOWN. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS PODO XINGDA ((B)(4)) MEDICAL CO. LTD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 59399 | ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP | IV ADMINISTRATION SET | FPA | INFUTRONIX, LLC | HS-002 | UNKNOWN | 00817170020048 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |