FDA Adverse Event
Malfunction
Summary report: N
ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP
MDR report key: 14059311
·
Received April 8, 2022
Report
- Report Number
- 3011581906-2022-00047
- Event Type
- Malfunction
- Date Received
- April 8, 2022
- Date of Event
- March 17, 2022
- Report Date
- April 6, 2022
- Manufacturer
- INFUTRONIX, LLC
- Product Code
- FPA
- PMA / PMN Number
- K153193
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
INFUTRONIX IS WAITING FOR THE AFFECTED DEVICE TO BE RETURNED FOR EVALUATION.
Description of Event or Problem · 0
ON (B)(6)2022, A DISTRIBUTOR OF INFUTRONIX REPORTED A COMPLAINT FROM A REGISTERED NURSE OF A USER FACILITY: "AN ADMINISTRATION SET MODEL HS-008-B; LOT 2103004 2 SETS LEAKED DURING AN INFUSION." THE REGISTERED NURSE STATED "POWDER WAS UNDER THE PUMP AND THERE WAS NONE ON THE BAG OR THE CONNECTION." DEVICE OPERATOR WAS UNKNOWN. MEDICATION INFUSED WAS 5FU. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS (B)(6) MEDICAL CO. LTD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1284036 | ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP | IV ADMINISTRATION SET | FPA | INFUTRONIX, LLC | 2103004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |