FDA Adverse Event
Injury
Summary report: N
INTEGRATED APD SET W/CASSETTE3 PRONG
MDR report key: 3180663
·
Received June 20, 2013
Report
- Report Number
- 1416980-2013-16032
- Event Type
- Injury
- Date Received
- June 20, 2013
- Date of Event
- March 7, 2013
- Report Date
- May 28, 2013
- Manufacturer
- BAXTER HEALTHCARE - MOUNTAIN HOME
- Product Code
- FKX
- PMA / PMN Number
- K923065
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. SAME PATIENT AS, (B)(4).
Additional Manufacturer Narrative · 1
(B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBERS: H13A15019, AND H12L11017. NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED.
Description of Event or Problem · 1
THIS IS REPORT 1 OF 2. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED. TREATMENT AND CAUSE OF PERITONITIS WAS NOT REPORTED. TEN DAYS LATER, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT RECOVERED FROM THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 280761 | INTEGRATED APD SET W/CASSETTE3 PRONG | HOMECHOICE AUTOMATED PD SET WITH CASSETTE | FKX | BAXTER HEALTHCARE - MOUNTAIN HOME |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Hospitalization | DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG |