FDA Adverse Event
Injury
Summary report: N
POLYFLUX REVACLEAR DIALYZER
MDR report key: 1971457
·
Received January 21, 2011
Report
- Report Number
- 3006552611-2011-00001
- Event Type
- Injury
- Date Received
- January 21, 2011
- Date of Event
- December 24, 2010
- Report Date
- December 27, 2010
- Manufacturer
- GAMBRO RENAL PRODUCTS
- Product Code
- KDI
- PMA / PMN Number
- K072232
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DIALYZER INVOLVED IN THIS INCIDENT WAS NOT AVAILABLE FOR INVESTIGATION AND LOT NUMBER COULD NOT BE PROVIDED BY FACILITY.
Description of Event or Problem · 1
FOLLOWING AN UNEVENTFUL HEMODIALYSIS TREATMENT ON A PHOENIX MACHINE, THE PT HAD A CARDIAC ARREST. THE MACHINE WAS INSPECTED BY GAMBRO TECHNICAL SPECIALIST REP WHO FOUND IT TO BE FUNCTIONING CORRECTLY AND WITHIN MANUFACTURER'S SPECIFICATIONS. THE DIALYSIS MACHINE WAS RETURNED TO CLINICAL USE. PER DCI CORPORATE POLICY, NO FURTHER PT, TREATMENT, OR DEVICE INFO WILL BE PROVIDED. NEITHER THE PHYSICIAN, NOR THE NURSES CARING FOR THE PT, BELIEVE ANY GAMBRO DEVICE CAUSED OR CONTRIBUTED TO THE PT'S CARDIAC ARREST. THE CARTRIDGE BLOOD SET, BICART AND REVACLEAR WERE REPORTED NOT AVAILABLE FOR INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POLYFLUX REVACLEAR DIALYZER | KDI | GAMBRO RENAL PRODUCTS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |