FDA Adverse Event
Malfunction
Summary report: N
ALARIS SYRINGE MODULE SET
MDR report key: 2251748
·
Received August 31, 2011
Report
- Report Number
- 9616066-2011-00503
- Event Type
- Malfunction
- Date Received
- August 31, 2011
- Report Date
- August 15, 2011
- Manufacturer
- CAREFUSION CORP.
- Product Code
- FPA
- PMA / PMN Number
- K811885
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER'S REPORT OF A SET LEAKING AT THE PRESSURE SENSING DISC COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE SET HAD BEEN DISCARDED BY THE CUSTOMER. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED.
Description of Event or Problem · 1
NURSE NOTED PUDDLE ON THE FLOOR AND FOUND SET LEAKING FROM THE AREA WHERE TUBING MEETS THE BOTTOM OF THE PRESSURE SENSING DISC (DISTAL SIDE OF DISC). NO ISSUES WERE NOTED ON PRIMING WHEN THE USER FLUSHED THE SET. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION REQUIRED. ALTHOUGH REQUESTED, NO FURTHER PATIENT OR EVENT INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALARIS SYRINGE MODULE SET | FPA | CAREFUSION CORP. | 10014914 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | ALARIS SYRINGE MODULE, SN: UNK| ALARIS PC UNIT, SN: UNK |