FDA Adverse Event
Injury
Summary report: N
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
MDR report key: 3131728
·
Received May 29, 2013
Report
- Report Number
- 1416980-2013-13508
- Event Type
- Injury
- Date Received
- May 29, 2013
- Date of Event
- May 2, 2013
- Report Date
- May 3, 2013
- Manufacturer
- BAXTER HEALTHCARE - MOUNTAIN HOME
- Product Code
- FKX
- PMA / PMN Number
- K923065
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H13A29119 AND H12L06108 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THIS IS REPORT 1 OF 3 INVOLVED IN THIS PERITONITIS EVENT. THIS IS A REPORT OF PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD). THE PATIENT WAS NOT HOSPITALIZED. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 236367 | HOMECHOICE AUTOMATED PD SET WITH CASSETTE | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE - MOUNTAIN HOME |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Other | TRANSFER SET, MINICAP| LOW CALCIUM YELLOW 1.5 % ULTRABAG| PD2 GREEN 2.5% SINGLEBAG, AND PURPLE EXTRANEAL |