FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
MDR report key: 2231758
·
Received September 1, 2011
Report
- Report Number
- 1423500-2011-11584
- Event Type
- Malfunction
- Date Received
- September 1, 2011
- Date of Event
- July 29, 2011
- Report Date
- August 12, 2011
- Manufacturer
- BAXTER HEALTHCARE - MOUNTAIN HOME
- Product Code
- FKX
- PMA / PMN Number
- K923065
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE LOT NUMBER WAS UNKNOWN, THEREFORE, NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.
Additional Manufacturer Narrative · 1
(B)(4). THIS REPORT OF A LEAK WAS NOT CONFIRMED, AND THE ROOT CAUSE WAS UNDETERMINED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BAXTER FOR ASSISTANCE WITH TROUBLESHOOTING AN ALARM, AND IT WAS DISCOVERED THERE WAS A LEAK IN THE CASSETTE. SINCE THEN, THE PATIENT HAS BEEN ABLE TO RESUME THERAPY SUCCESSFULLY. THERE WAS PATIENT INVOLVEMENT BUT NO REPORTED INJURY OR MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOMECHOICE AUTOMATED PD SET WITH CASSETTE | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE - MOUNTAIN HOME |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | HOME CHOICE |