FDA Adverse Event
Malfunction
Summary report: N
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
MDR report key: 3123961
·
Received May 22, 2013
Report
- Report Number
- 1416980-2013-13110
- Event Type
- Malfunction
- Date Received
- May 22, 2013
- Date of Event
- May 2, 2013
- Report Date
- May 2, 2013
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- FKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT 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 SYSTEM ERROR 2367 (RESUME ERROR, CRITICAL ERROR FOUND) ALARM OCCURRED ON A HOMECHOICE (HC) MACHINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) IN CLEARING THE ALARM AND REMOVING THE CASSETTE. THE TSR ADVISED THE HP TO RESTART THERAPY WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 225766 | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | HOMECHOICE |