N
Patient 1
(B)(4). A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
MAUDE MDR 6545745
- MDR report key
- 6545745
- Report number
- 1625685-2017-00288
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-04-07
- Date received
- 2017-05-04
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- ANNA WEHRHEIM
- Address
- 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | DENVER SHUNTS | SHUNT, PERITONEAL | CAREFUSION, INC | KPM | DENVER SHUNTS | UNKNOWN | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-05-04 | 0 | 1. D |
Event Narratives#
D
Patient 1
DOCTOR REPORTED VIA TELEPHONE: PATIENT EXPIRED 5-6 DAYS AFTER THE DENVER SHUNT WAS PLACED. HE STATES IT WAS PLACED ON THE STERNUM TO PLACE PRESSURE ON THE VALVE AND THIS CAUSED DISCOMFORT TO THE PATIENT BUT HE HAS NO REASON TO BELIEVE IT WAS NOT FUNCTIONING PROPERLY. DUE DILIGENCE COMPLETED AND NO ADDITIONAL INFORMATION PROVIDED.
N
Patient 1
(B)(4). NO SAMPLE WAS PROVIDED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR THE COMPLAINT, THUS WE WERE UNABLE TO PERFORM A DEVICE HISTORY RECORD FOR REVIEW. BELOW INFORMATION WAS PROVIDED TO ACTUAL REPORTER ON (B)(6) 2017. BASED ON THE INQUIRY PROVIDED BY THE CUSTOMER, THE FOLLOWING RESPONSE IS PROVIDED REGARDING THE BASIC PERFORMANCE OF THE SHUNT DEVICE: EVERY SHUNT PRODUCED IS TESTED FOR FLOWRATE, BACKFLOW AND REFLUX AT THE TIME OF MANUFACTURING. THE VALVES IN THE SHUNT ARE DESIGNED TO OPEN AT 3CM WATER PRESSURE, REGARDLESS OF POSITION (VERTICAL OR HORIZONTAL), AND TO REMAIN CLOSED TO BACKFLOW WHEN REVERSE PRESSURE IS APPLIED. FOR MOST ASCITES PATIENTS, THE MAJORITY OF FLUID FLOW WILL OCCUR WHEN THE PATIENT IS LYING DOWN BECAUSE THE FLUID DOESN?T NEED TO OVERCOME THE PRESSURE GRADIENT PROVIDED BY THE HEIGHT DIFFERENCE BETWEEN THE PERITONEAL AND VENOUS CATHETERS. HOWEVER, IF ENOUGH PRESSURE BUILDS UP IN THE ABDOMEN, THE FLUID WILL STILL BE ABLE TO FLOW. ADDITIONALLY, PATIENTS ARE INSTRUCTED TO PUMP THE CHAMBER 20 TIMES IN THE MORNING AND 20 TIMES AT NIGHT TO ENSURE THE SHUNT REMAINS PATENT.