MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-05-04 for DENVER SHUNTS manufactured by Carefusion, Inc.
[74447444]
(b)(4). A follow up emdr will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[74447445]
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.
Patient Sequence No: 1, Text Type: D, B5
[77668054]
(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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1625685-2017-00288 |
| MDR Report Key | 6545745 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-05-04 |
| Date of Report | 2017-06-06 |
| Date of Event | 2017-04-07 |
| Date Mfgr Received | 2017-04-12 |
| Date Added to Maude | 2017-05-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANNA WEHRHEIM |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 400 EAST FOSTER RD |
| Manufacturer City | MANNFORD OK 74044 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 74044 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DENVER SHUNTS |
| Generic Name | SHUNT, PERITONEAL |
| Product Code | KPM |
| Date Received | 2017-05-04 |
| Model Number | DENVER SHUNTS |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-05-04 |