FDA Adverse Event
Other
Summary report: N
ASAHI EXCEED SERIES DIALYZER
MDR report key: 1673223
·
Received April 30, 2010
Report
- Report Number
- 3007340888-2010-00002
- Event Type
- Other
- Date Received
- April 30, 2010
- Date of Event
- March 22, 2010
- Report Date
- April 1, 2010
- Manufacturer
- ASAHI KASEI KURARAY MEDICAL CO. LTD.
- Product Code
- KDI
- PMA / PMN Number
- K082515
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT IN COMPLAINT WAS NOT RETURNED TO THE MFR AND COULD NOT BE ANALYZED. THE LOT NUMBER IN COMPLAINT WAS NOT REPORTED AND COULD NOT REVIEW THE MFG AND QUALITY CONTROL RECORDS.
Description of Event or Problem · 1
IMMEDIATELY AT ONSET OF TREATMENT, THE PT COMPLAINED NAUSEA. ALMOST IMMEDIATELY THE PT WENT INTO SEIZURES AND HAD CARDIAC AND RESPIRATORY ARREST. CPR WAS PERFORMED ON THE PT AND TRANSPORTED TO ER. HOSPITALIZED FOR TWO DAYS, AND THE PT WAS IN THE SATISFACTORY CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASAHI EXCEED SERIES DIALYZER | KDI | ASAHI KASEI KURARAY MEDICAL CO. LTD. | REXEED-25SX | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Hospitalization |