6" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®, 0.2 MICRON FILTER, 3 CLAMPS, ROTAT
Report
- Report Number
- 9617594-2024-00414
- Event Type
- Malfunction
- Date Received
- April 12, 2024
- Date of Event
- March 1, 2024
- Report Date
- April 12, 2024
- Manufacturer
- ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
- Product Code
- FMG
- UDI-DI
- 00887709007192
- PMA / PMN Number
- K964435
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
THE DEVICE HAS BEEN DISCARDED AND IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE A PROBABLE CAUSE IS UNABLE TO BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
THE EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A 6" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®, 0.2 MICRON FILTER, 3 CLAMPS, ROTATING LUER. THE CUSTOMER STATED THAT ON (B)(6)2024 AT 12:36AM RISK RDE REPORTED THAT AN INFANT WITH PERIPHERAL INTRAVENOUS (IV) ACCESS WITH A TRIFUSE INFUSING TOTAL PARENTERAL NUTRITION (TPN), LIPIDS AND A MEDICATION LINE HAD A LEAK. THE REGISTERED NURSE (RN) NOTED THAT THE TPN WAS LEAKING AT THE TPN FILTER ON THE TRIFUSE AS LINEN WAS SATURATED AND THE TRIFUSE IS STICKY TO TOUCH. THE EVENT OCCURRED DURING INFUSION. THERE WAS PATIENT INVOLVED AND UNKNOWN PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 809145 | 6" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®, 0.2 MICRON FILTER, 3 CLAMPS, ROTAT | STOPCOCK, I.V. SET | FMG | ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. | 13766552 | 00887709007192 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | LIPIDS, MFR UNK| TOTAL PARENTERAL NUTRITION (TPN), MFR UNK| UNSPECIFIED MEDICATION, MFR UNK |