MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-18 for SHUNT DENVER ASCITES DOUBLE VALVE 42-2000 manufactured by Carefusion, Inc.
[95774273]
(b)(4) initial emdr submission. A follow up emdr will be submitted if additional information becomes available. (b)(4). Device not returned, no lot number provided.
Patient Sequence No: 1, Text Type: N, H10
[95774274]
Symptomatic patient with ascites. Denver shunt, inserted in 2017, not pumping. Radiologist concerned about pump chamber and/or venous catheter being blocked. Advised to check that the pump chamber and venous catheter are not blocked. Replace with new denver shunt. Double-pak.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625685-2017-00422 |
| MDR Report Key | 7125715 |
| Date Received | 2017-12-18 |
| Date of Report | 2017-12-18 |
| Date of Event | 2017-11-30 |
| Date Mfgr Received | 2017-12-01 |
| Date Added to Maude | 2017-12-18 |
| 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 | BDX ANNA WEHRHEIM |
| Manufacturer Street | 75 N. FAIRVIEW 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SHUNT DENVER ASCITES DOUBLE VALVE |
| Generic Name | SHUNT, PERITONEAL |
| Product Code | KPM |
| Date Received | 2017-12-18 |
| Catalog Number | 42-2000 |
| Lot Number | UNKNOWN |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 400 EAST FOSTER RD MANNFORD OK 74044 US 74044 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-18 |