FDA Adverse Event
Malfunction
Summary report: N
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
MDR report key: 4192872
·
Received October 22, 2014
Report
- Report Number
- 1416980-2014-36911
- Event Type
- Malfunction
- Date Received
- October 22, 2014
- Date of Event
- September 27, 2014
- Report Date
- September 27, 2014
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT 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 AIR WAS OBSERVED IN THE PATIENT LINE OF THE CASSETTE DURING THE DWELL THREE OF FOUR ON THE HOMECHOICE. THE HOME PATIENT (HP) INDICATED THAT THE PATIENT LINE HAD BECOME DISCONNECTED FROM THE TRANSFER SET. THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED THE HP TO END THERAPY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 673443 | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | HOMECHOICE, TRANSFER SET |