FDA Adverse Event
Injury
Summary report: N
MINI-CAP
MDR report key: 3152765
·
Received June 8, 2013
Report
- Report Number
- 1416980-2013-14549
- Event Type
- Injury
- Date Received
- June 8, 2013
- Report Date
- May 14, 2013
- Manufacturer
- BAXTER HEALTHCARE - CLEVELAND
- Product Code
- KDI
- PMA / PMN Number
- K895631
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). DATE OF OCCURRENCE IS UNKNOWN IN (B)(6) 2013. A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT GD893560, AND NO ISSUES WERE DETECTED DURING THE MANUFACTURING OF THIS BATCH. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
THIS IS REPORT 2 OF 2. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS. THE PATIENT WAS RECOVERING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 254483 | MINI-CAP | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | KDI | BAXTER HEALTHCARE - CLEVELAND |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | DIANEAL PD4 AMBUFLEX |