D
Patient 1
THIS DEVICE AND ALL LEADS EXPLANTED DUE TO INFECTION. THIS DEVICE WAS REPLACED WITH A PHILOS II SR, IN 2009. THIS DEVICE WAS DISCARDED BY THE HOSPITAL.
MAUDE MDR 1482854
- MDR report key
- 1482854
- Report number
- 1423500-2009-00430
- Event key
- 0
- Event type
- 3
- Date of event
- 2009-08-27
- Date received
- 2009-09-25
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- KAREN KIRBY
- Address
- 25212 W. ILLINOIS ROUTE 120 ROUND LAKE IL 60073 US
- Phone
- 847-847-8472
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | U0707 TINA DOUBLE PUMP CE LCD | SYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT | BAXTER HEALTHCARE - LARGO | FKP | S1000L3TD | R | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2009-09-25 | 0 |
Event Narratives#
N
Patient 1
THE HEATER ASSEMBLY OF THE DEVICE WAS EVALUATED IN THE BAXTER PRODUCT ANALYSIS LAB (PAL) FOR THE REPORTED ISSUE OF THE HEATER HAD CAUGHT ON FIRE IN THE MACHINE DURING NIGHT TIME, WHEN THE DEVICE WAS NOT IN USE. NO PATIENT WAS CONNECTED TO THE DEVICE. THE HEATER THAT WAS RECEIVED BY THE PAL LAB IS A MODEL THEY HAD NOT SEEN BEFORE. THEY DO NOT HAVE ANY RECORD OF THIS KIND OF HEATER EVER BEING USED. THIS HEATER DOES NOT HAVE A THERMAL SWITCH BREAKER. THE HEATER WAS CHECKED AND IT DID NOT SHOW ANY OBVIOUS PROBLEMS (HEATER WAS NOT SHORTED). THE ASSIGNABLE CAUSE WAS NOT DETERMINED BY ENGINEER. BAXTER REQUIRES THAT THE DIALYSIS INSTRUMENT IS CONNECTED TO A GFCI (GROUND FAULT CIRCUIT INTERRUPTER) OUTLET AS A PRECAUTIONARY MEASURE. THE MACHINE WAS NOT CONNECTED TO A GFCI. RETURNED PARTS WILL BE SCRAPPED.
D
Patient 1
THIS IS A CASE REPORT, RECEIVED BY BAXTER REPORTED FROM A DISTRIBUTOR. IT WAS REPORTED TO THEM BY THEIR LOCAL CUSTOMER DIALYSIS CENTER. IT WAS REPORTED THAT A TINA HEMODIALYSIS MACHINE WAS FOUND HEAVILY BURNED BY A FIRE CAUSED BY THE HEATING ELEMENT OF THE MACHINE IN 2009. IT WAS NOTICED BY THE NURSE. THE FIRE IN THE MACHINE WAS DURING THE NIGHT, WHEN THE DEVICE WAS NOT IN USE. NO PATIENT WAS CONNECTED TO THE DEVICE. SEVERAL COMPONENTS ARE BURNED, BUT ARE AVAILABLE FOR INVESTIGATION. THE CUSTOMER STATED THAT THERE WAS NO VISIBLE SMOKE COMING FROM MACHINE, IN THE MORNING WHEN THE NURSE FIRST NOTICED THE INCIDENT.
N
Patient 1
.