FDA Adverse Event
Malfunction
Summary report: N
CRIT-LINE BLOOD CHAMBER
MDR report key: 3982871
·
Received June 25, 2014
Report
- Report Number
- 2937457-2014-01547
- Event Type
- Malfunction
- Date Received
- June 25, 2014
- Date of Event
- June 3, 2014
- Report Date
- June 6, 2014
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KOC
- PMA / PMN Number
- K935958
- Removal / Correction Number
- Z-1716-2015
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. A PRODUCT RECALL HAS BEEN INITIATED BY THE MANUFACTURER AND THE REPORTED PRODUCT ISSUE IS BEING INVESTIGATED BY THE MANUFACTURER VIA A CPA.
Additional Manufacturer Narrative · 1
THE 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 REPORTED THAT DURING TREATMENT, A BLOOD LEAK OCCURED. THE LEAK WAS VISUALLY OBSERVED COMING FROM WHERE THE CHAMBER MEETS THE ARTERIAL END FO THE DIALYZER AND DRIPPING ON THE FLOOR. ESTIMATED BLOOD LOSS WAS LESS THAN 100CC'S. PATIENT HAD NO ADVERSE EFFECTS AND DID NOT REQUIRE ANY MEDICAL INTERVENTION. SAMPLE IS NOT AVAILABLE; SAMPLE WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 370559 | CRIT-LINE BLOOD CHAMBER | KOC | FRESENIUS MEDICAL CARE NORTH AMERICA | 14031304 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |