FDA Adverse Event
Malfunction
Summary report: N
MINICAP TRANSFER SET
MDR report key: 3120901
·
Received May 20, 2013
Report
- Report Number
- 1416980-2013-12983
- Event Type
- Malfunction
- Date Received
- May 20, 2013
- Report Date
- April 23, 2013
- Manufacturer
- BAXTER HEALTHCARE - MOUNTAIN HOME
- Product Code
- KDJ
- PMA / PMN Number
- K882498
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TRANSFER SET BECAME DISCONNECTED FROM THE TITANIUM ADAPTER. THE REPORTER STATED THAT "THE WHITE PLASTIC PART CONNECTED TO THE TITANIUM ADAPTER LOOKED DEFECTIVE." THE ISSUE OCCURRED WHEN THE PATIENT JUST HAD THEIR TRANSFER SET CHANGED. THE ISSUE WAS RESOLVED WHEN THE TRANSFER SET WAS CHANGED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 222263 | MINICAP TRANSFER SET | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE. | KDJ | BAXTER HEALTHCARE - MOUNTAIN HOME |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |