FDA Adverse Event
Malfunction
Summary report: N
CUSTOM COMBI SET
MDR report key: 4230715
·
Received October 22, 2014
Report
- Report Number
- 8030665-2014-00819
- Event Type
- Malfunction
- Date Received
- October 22, 2014
- Date of Event
- October 8, 2014
- Report Date
- October 8, 2014
- Manufacturer
- REYNOSA PLANT
- Product Code
- FJK
- PMA / PMN Number
- K962081
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PLANT INVESTIGATION HAS NOT YET BEEN COMPLETED. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
A HEMODIALYSIS INPATIENT USER FACILITY HAS REPORTED THAT DURING TREATMENT, A BLOOD LEAK OCCURRED. THE LEAK WAS VISUALLY OBSERVED. THE HEPARIN LINE SEPARATED FROM THE BLOOD LINE. TEST STRIPS WERE NOT USED TO CONFIRM AND THE MACHINE DID NOT ALARM DUE TO LEAK BEING EXTERNAL. ESTIMATED BLOOD LOSS WAS 300 CC. THE PT HAD NO ADVERSE EFFECTS AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PT COMPLETED TREATMENT WITH A NEW SET UP. SAMPLE AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 670896 | CUSTOM COMBI SET | FJK | REYNOSA PLANT | 14ER01048 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | FRESENIUS 2008K HEMODIALYSIS MACHINE |