FDA Adverse Event
Injury
Summary report: N
NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET
MDR report key: 4931660
·
Received July 22, 2015
Report
- Report Number
- 8041145-2015-00054
- Event Type
- Injury
- Date Received
- July 22, 2015
- Date of Event
- February 20, 2013
- Report Date
- July 22, 2013
- Manufacturer
- NIPRO THAILAND CORPORATION LTD
- Product Code
- FJK
- PMA / PMN Number
- K072024
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER INVESTIGATION REPORT ON RETAINED AND RETURNED SAMPLES.
Description of Event or Problem · 1
1 HOUR AFTER DIALYSIS TREATMENT WAS INITIATED, WITH A BLOOD FLOW RATE OF 400ML/MIN, PATIENT WITH AV GRAFT, DEVELOPED NAUSEA, MALAISE, EPISTAXIS, VOMITING, RESULTING IN HEMOLYSIS, DETECTABLE IN THE BLOOD. NURSE NOTICED A KINK IN THE BLOOD TUBING SET IN FRONT OF THE ARTERIAL DRIP CHAMBER ABOUT 100MM IN LENGTH. PATIENT WAS SENT TO THE ICU FOR FURTHER TREATMENT. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 474497 | NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET | BLOOD TUBING SET | FJK | NIPRO THAILAND CORPORATION LTD | A252R/V777R | 12I06 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |