FDA Adverse Event
Malfunction
Summary report: N
AUTOMATED PD SET W/CASSETTE4 PRONG
MDR report key: 1893480
·
Received November 8, 2010
Report
- Report Number
- 1423500-2010-05472
- Event Type
- Malfunction
- Date Received
- November 8, 2010
- Date of Event
- October 6, 2010
- Report Date
- October 15, 2010
- Manufacturer
- BAXTER HEALTHCARE - MOUNTAIN HOME
- Product Code
- FKX
- PMA / PMN Number
- K923065
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) THAT OCCURRED DURING USE WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE CAUSE WAS UNDETERMINED. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).
Additional Manufacturer Narrative · 1
(B)(4). SINCE THE CUSTOMER DID NOT REPORT THIS ALARM AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED AND THERE IS NO LOT INFORMATION. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
DURING INITIAL ASSESSMENT OF A HOMECHOICE DEVICE, A BAXTER TECHNICIAN IDENTIFIED A 2240 ALARM (INDICATING AIR) WHICH OCCURRED ON (B)(6) 2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTOMATED PD SET W/CASSETTE4 PRONG | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE - MOUNTAIN HOME |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR |