FDA Adverse Event
Malfunction
Summary report: N
MAXGUARD EXTENSION SET
MDR report key: 8851963
·
Received August 1, 2019
Report
- Report Number
- 9616066-2019-02163
- Event Type
- Malfunction
- Date Received
- August 1, 2019
- Date of Event
- July 3, 2019
- Report Date
- July 10, 2019
- Manufacturer
- CAREFUSION
- Product Code
- FPA
- UDI-DI
- 10885403236112
- PMA / PMN Number
- K051499
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED COMPLAINT BECAUSE THE SET HAS BEEN DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED. PATIENT AGE AND DOB REQUESTED BUT NOT PROVIDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS IN DIABETIC KETOACIDOSIS (DKA) RECEIVING A DKA PROTOCOL INFUSION OF DKA FLUIDS AND INSULIN WHEN THE TRIFUSE TUBING SET LEAKED AT THE JUNCTION OF THE 3 ARMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 644075 | MAXGUARD EXTENSION SET | SET, ADMINISTRATION, INTRAVASCULAR | FPA | CAREFUSION | ME1224 | 17115444 | 10885403236112 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |