FDA Adverse Event
Malfunction
Summary report: N
MINICAP
MDR report key: 4100936
·
Received September 19, 2014
Report
- Report Number
- 1416980-2014-32152
- Event Type
- Malfunction
- Date Received
- September 19, 2014
- Report Date
- August 27, 2014
- Manufacturer
- BAXTER HEALTHCARE - CLEVELAND
- Product Code
- KDI
- PMA / PMN Number
- K895631
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER UNKNOWN, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT OBSERVED A MINICAP WITH A DRY SPONGE. THIS OCCURRED DURING USE WHILE PERFORMING AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY. THE PATIENT REPORTED NOT SEEING IODINE FLOW THROUGH THE LINE AFTER THE FRANGIBLE WAS BROKEN, INDICATING THAT THE SPONGE WAS DRY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 584969 | MINICAP | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | KDI | BAXTER HEALTHCARE - CLEVELAND |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |