FDA Adverse Event
Injury
Summary report: N
MINICAP
MDR report key: 3172591
·
Received June 17, 2013
Report
- Report Number
- 1416980-2013-15516
- Event Type
- Injury
- Date Received
- June 17, 2013
- Report Date
- May 24, 2013
- Manufacturer
- BAXTER HEALTHCARE - CLEVELAND
- Product Code
- KDI
- PMA / PMN Number
- K895631
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED ON POTENTIALLY ASSOCIATED LOT NUMBER GD894170 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. SAME PATIENT AS (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THIS IS REPORT 2 OF 3. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ACTION TAKEN WITH DIANEAL THERAPIES WAS NOT REPORTED. TREATMENT WAS NOT REPORTED. PATIENT OUTCOME WAS NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 273223 | MINICAP | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | KDI | BAXTER HEALTHCARE - CLEVELAND |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG |