FDA Adverse Event
Injury
Summary report: N
9616240-2008-00038
MDR report key: 1080686
·
Received July 11, 2008
Report
- Report Number
- 9616240-2008-00038
- Event Type
- Injury
- Date Received
- July 11, 2008
- Product Code
- FII
- PMA / PMN Number
- K001156
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
ACCORDING TO THE CLINIC, THE MACHINE HAD RECEIVED A PREVENTIVE MAINTENANCE OVER THIRTEEN MOS PRIOR TO THE EVENT. THE HOSPITAL HAS SIXTY-SIX PHOENIX MACHINES LOCATED IN THREE AFFILIATED UNITS. ALL OF THE MACHINES HAVE BEEN INSPECTED BY THE LOCAL TECHNICIAN IN ORDER TO VERIFY THAT THE CONCENTRATE LINES WERE SECURELY ATTACHED TO THE CONCENTRATE CONNECTORS. THREE MACHINES PRESENTED WITH PLASTIC "TIE-WRAP" RATHER THAN A METAL CLIP SECURING THE TUBING ONTO ONE OF THE MALE CONNECTOR ASSEMBLIES. REPLACEMENT METAL CLIPS HAVE BEEN ORDERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FII |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |