FDA Adverse Event
Injury
Summary report: N
9616240-2008-00037
MDR report key: 1080684
·
Received July 11, 2008
Report
- Report Number
- 9616240-2008-00037
- 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, FIVE WEEKS BEFORE THE EVENT, THE LOCAL TECHNICIAN PERFORMED A PREVENTIVE MAINTENANCE ON THE PHOENIX MACHINE REPLACING THE ACID/ACETATE, THE BIOCARBONATE MALE AND FEMALE CONCENTRATE CONNECTORS. 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 LINENS WERE SECURELY ATTACHED TO THE CONCENTRATE CONNECTORS. THREE MACHINES PRESENTED WITH PLASTIC "TIE-WRAP" RATHER THEN 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 |