FDA Adverse Event
Injury
Summary report: N
OPTIFLUX 160NRE DIALYZER FINISHED ASSY.
MDR report key: 2140925
·
Received June 21, 2011
Report
- Report Number
- 1713747-2011-00020
- Event Type
- Injury
- Date Received
- June 21, 2011
- Date of Event
- March 8, 2011
- Report Date
- June 21, 2011
- Manufacturer
- OGDEN MANUFACTURING
- Product Code
- FJI
- PMA / PMN Number
- K002761
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PT PRESENTED TO THE HEMODIALYSIS CLINIC ALERT AND AMBULATORY BUT APPEARED WEAK AND PALE. PT'S DIALYZER RINSED WITH 2 LITERS OF NORMAL SALINE AND PT WAS ADMINISTERED SOLU CORTEF 100 MG AS ORDERED AT THE INITIATION OF TREATMENT. STARTED 100 BLOOD FLOW AND 200 ML'S OF NORMAL SALINE GIVEN ALONG WITH O2 2LPM VIA NASAL CANNULA. SIX MINUTES INTO TREATMENT, THE PT BECAME ANXIOUS BUT REMAINED ALERT. THE PT WAS PLACED IN TRENDELENBURG AND BLOOD RETURNED WITHIN 500 ML'S OF NORMAL SALINE. SHE WAS TAKEN OFF DIALYSIS BUT BECAME HYPOTENSIVE WITH BP 63/30 AND UNRESPONSIVE. PT RESPONDED TO 1300 ML'S OF ADDITIONAL SALINE AND REGAINED CONSCIOUSNESS BP 153/35. PT WAS ADMITTED TO THE HOSPITAL FOR EVALUATION. NO FURTHER INFO HAS BEEN OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OPTIFLUX 160NRE DIALYZER FINISHED ASSY. | HEMODIALYSIS DIALYZER | FJI | OGDEN MANUFACTURING | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Hospitalization| L| R |