MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-09-22 for PLEURAFLOW SYSTEM PF-32 manufactured by Clearflow, Inc.
[89288939]
The device was in the anterior mediastinum. The clearance loop separation was noticed about 9 hours after surgery in the cvicu. An x-ray was taken and showed that the clearance loop was inside the chest tube. The clearance apparatus was removed and the chest tube was connected to the drainage canister. At end of use a ct scan confirmed that the loop was not in the chest.
Patient Sequence No: 1, Text Type: N, H10
[89288940]
Clearance loop separated from clearance wire during use
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008782989-2017-00006 |
| MDR Report Key | 6888974 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-09-22 |
| Date of Event | 2017-09-03 |
| Date Added to Maude | 2017-09-22 |
| 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 | DR. DOV GAL |
| Manufacturer Street | 1630 S. SUNKIST ST. SUITE E |
| Manufacturer City | ANAHEIM CA 928065816 |
| Manufacturer Country | US |
| Manufacturer Postal | 928065816 |
| Manufacturer Phone | 7149165014 |
| Manufacturer G1 | XERIDIEM MEDICAL DEVICES |
| Manufacturer Street | 4700 SOUTH OVERLAND DR. |
| Manufacturer City | TUCSON AZ 85714 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85714 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLEURAFLOW SYSTEM |
| Generic Name | PLEURAFLOW SYSTEM |
| Product Code | OTK |
| Date Received | 2017-09-22 |
| Model Number | PF-32 |
| Catalog Number | PF-32 |
| Lot Number | 964307 |
| Operator | NURSE |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLEARFLOW, INC |
| Manufacturer Address | 1630 S. SUNKIST ST. SUITE E ANAHEIM CA 928065816 US 928065816 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-22 |