FDA Adverse Event
Injury
Summary report: N
MINICAP
MDR report key: 2032804
·
Received March 29, 2011
Report
- Report Number
- 1423500-2011-03796
- Event Type
- Injury
- Date Received
- March 29, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 11, 2011
- Manufacturer
- BAXTER HEALTHCARE - CLEVELAND
- Product Code
- KDI
- PMA / PMN Number
- K895631
- 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 AND UNRELATED ALARM. THEY REPORTED THAT THE PATIENT HAD ACQUIRED PERITONITIS AND WENT TO THE HOSPITAL THE DAY OF THE ALARM (B)(6) 2011. THE CARE GIVER 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 | MINICAP | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | KDI | BAXTER HEALTHCARE - CLEVELAND |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | DIANEAL LOW CAL(PD4) AMBUFLEX| HOME CHOICE CYCLER |