FDA Adverse Event
Malfunction
Summary report: N
560/570 SERIES PRIMARY INFUSION SET
MDR report key: 2251728
·
Received August 31, 2011
Report
- Report Number
- 9616066-2011-00471
- Event Type
- Malfunction
- Date Received
- August 31, 2011
- Date of Event
- July 22, 2011
- Report Date
- August 9, 2011
- Manufacturer
- CAREFUSION CORP.
- Product Code
- FPA
- PMA / PMN Number
- K811110
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PATIENT INFORMATION REQUESTED AND ALL AVAILABLE INFORMATION IS INCLUDED. ALTHOUGH REQUESTED, THE INFUSION SET HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE/INVESTIGATION RESULTS SHOULD THE SET BE RECEIVED FOR EVALUATION.
Description of Event or Problem · 1
THE USER REPORTED THAT DURING AN INFUSION, THEY NOTICED AIR IN THE LINE AND ON CLOSER INSPECTION FOUND A CRACK IN THE PRESSURE DISC. FROM THE REPORTED INFORMATION, THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PATIENT OR USER AS A RESULT OF THIS INCIDENT. ALTHOUGH REQUESTED, NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 560/570 SERIES PRIMARY INFUSION SET | FPA | CAREFUSION CORP. | 5227FE | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |