FDA Adverse Event
Malfunction
Summary report: N
MINICAP
MDR report key: 4123256
·
Received September 26, 2014
Report
- Report Number
- 1416980-2014-33486
- Event Type
- Malfunction
- Date Received
- September 26, 2014
- Date of Event
- September 3, 2014
- Report Date
- September 3, 2014
- Manufacturer
- BAXTER HEALTHCARE - MOUNTAIN HOME
- Product Code
- KDI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4). AS THE SAMPLE WAS NOT RETURNED, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AS THE HOME PATIENT WAS ABOUT TO CONNECT TO THE SETUP FOR PERITONEAL DIALYSIS ON THE HOMECHOICE, THE CAREGIVER (CG) DISCOVERED THAT THE MINICAP WAS MISSING FROM THE TRANSFER SET LINE. THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED THE CG IN ENDING THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 602713 | MINICAP | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | KDI | BAXTER HEALTHCARE - MOUNTAIN HOME |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | TRANSFER SET |