FDA Adverse Event
Injury
Summary report: N
MINICAP TRANSFER SET
MDR report key: 3230681
·
Received July 16, 2013
Report
- Report Number
- 1416980-2013-18727
- Event Type
- Injury
- Date Received
- July 16, 2013
- Report Date
- June 21, 2013
- Manufacturer
- BAXTER HEALTHCARE - MOUNTAIN HOME
- Product Code
- KDJ
- PMA / PMN Number
- K882498
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H13B07048 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED RECURRENT PERITONITIS. THE PT WAS HOSPITALIZED FOUR TIMES WITHIN THE PREVIOUS TWO MONTHS FOR RECURRENT PERITONITIS. TREATMENT WAS NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 4 OF 4 INVOLVED IN THIS PERITONITIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 330055 | MINICAP TRANSFER SET | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE | KDJ | BAXTER HEALTHCARE - MOUNTAIN HOME |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization | MINICAP| CAPD DISCONNECT Y SET| HOMECHOICE AUTOMATED PD SET WITH CASSETTE |