FDA Adverse Event
Injury
Summary report: N
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
MDR report key: 2032816
·
Received March 29, 2011
Report
- Report Number
- 1423500-2011-03797
- Event Type
- Injury
- Date Received
- March 29, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 11, 2011
- Manufacturer
- BAXTER HEALTHCARE - MOUNTAIN HOME
- Product Code
- FKX
- PMA / PMN Number
- K923065
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): AS PATIENT DISCARDS SUPPLIES AFTER EACH USE, A SAMPLE WAS NOT AVAILABLE FOR EVALUATION. FOLLOW UP WILL BE SUBMITTED AS INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
ON (B)(6) 2011, THE CAREGIVER RETURNED A CALL TO BAXTER REGARDING AN UNRELATED ALARM. THEY REPORTED THAT THE PATIENT HAD ACQUIRED PERITONITIS AND WENT TO THE HOSPITAL THE DAY OF THE ALARM (B)(6) 2011. THE CAREGIVER REPORTED THAT THE PATIENT HAS SINCE BEEN RELEASED FROM THE HOSPITAL AND HE IS ON ANTIBIOTICS. THE CAREGIVER REPORTED THE PATIENT WAS PERFORMING PERITONEAL DIALYSIS (PD) THERAPY SUCCESSFULLY AGAIN. NO FURTHER INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOMECHOICE AUTOMATED PD SET WITH CASSETTE | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE - MOUNTAIN HOME |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | DIANEAL LOW CAL (PD4) AMBUFLEX| HOME CHOICE CYCLER |