FDA Adverse Event
Other
Summary report: N
ASAHI REXEED SERIES DIALYZER
MDR report key: 1673224
·
Received April 30, 2010
Report
- Report Number
- 3007340888-2010-00001
- Event Type
- Other
- Date Received
- April 30, 2010
- Date of Event
- February 10, 2010
- Report Date
- March 26, 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 MANUFACTURER AND COULD NOT BE ANALYZED. THE LOT NUMBER IN COMPLAINT WAS NOT REPORTED AND COULD NOT REVIEW THE MANUFACTURING AND QUALITY CONTROL RECORDS.
Description of Event or Problem · 1
FORTY MINUTES AFTER STARTING THE TREATMENT, THE PT COMPLAINT COLD AND SHIVERING (TEMP 97.2F) AND NOISY, LABORED BREATHING WAS OBSERVED. THE TREATMENT WAS TERMINATED AND THE PT WAS SENT TO EMERGENCY ROOM AND WAS ON VENTILATOR OVER THE NIGHT. THE PT WAS HOSPITALIZED FOR THREE DAYS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASAHI REXEED SERIES DIALYZER | KDI | ASAHI KASEI KURARAY MEDICAL CO. LTD. | REXEED-21SX | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Hospitalization |