FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE AUTOMATED PD SET W/CASS.-4 PRONG, EUR.
MDR report key: 1843415
·
Received September 24, 2010
Report
- Report Number
- 1423500-2010-03682
- Event Type
- Malfunction
- Date Received
- September 24, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 2, 2010
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FKX
- PMA / PMN Number
- K923065
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THE TAPE AROUND THE PATIENT LINE WAS TOO LOOSE. THE ROOT CAUSE WAS UNDETERMINED. A BATCH REVIEW WAS PERFORMED WITH NO DEFECTS NOTED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.
Description of Event or Problem · 1
A CUSTOMER REPORTED THE WHITE PAPER TAPE ON THE PATIENT LINE WAS TOO LOOSE SO THE PATIENT LINE DROPPED AND TOUCHED THE FLOOR WHEN FIXING THE SETS TO THE HOMECHOICE. THE TAPE WAS CONSEQUENTLY REMOVED AND THEREFORE NO SAMPLES ARE AVAILABLE. NO PATIENT INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOMECHOICE AUTOMATED PD SET W/CASS.-4 PRONG, EUR. | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE - SINGAPORE | S10A13108 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |