FDA Adverse Event
Malfunction
Summary report: N
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
MDR report key: 3171119
·
Received June 14, 2013
Report
- Report Number
- 1416980-2013-15444
- Event Type
- Malfunction
- Date Received
- June 14, 2013
- Date of Event
- May 21, 2013
- Report Date
- May 22, 2013
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- FKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. THEREFORE, NO ANALYSIS CAN BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4). UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED BY THE REGISTERED NURSE (RN) THAT THE AIR WAS NOTICED IN THE PATIENT LINE AT THE END OF THE PRIMING STAGE OF THE PERITONEAL DIALYSIS THERAPY, WHILE THE HOME PATIENT (HP) WAS NOT CONNECTED. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 270946 | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | HOMECHOICE |