MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2015-11-13 for PLEURAFLOW SYSTEM PF-28 manufactured by Clearflow, Inc..
[31078225]
Based on the location of the chest tube and the forensic pathology opinion, it is unlikely that the reported subcutaneous emphysema, suggesting lung air leak, was related to this device problem. This is a complication known to occur in at least 1. 4% of patients after heart surgery (http://www. Ncbi. Nlm. Nih. Gov/pubmed/12034391). This is managed with pleural chest tubes, which, in this case, was already in place. Thus, no additional treatments were required and this did not impact the patient's uneventful recovery from surgery.
Patient Sequence No: 1, Text Type: N, H10
[31078226]
The patient was transferred from another hospital for an urgent coronary artery bypass surgery. Surgery was done on (b)(6), 2015. Patient had pre-existing conditions including coronary artery disease (cad), congestive heart failure (chf), high blood pressure (htn), and diabetes mellitus (dm) type ii. Following surgery the patient had one pleuraflow chest tube placed in the mediastinum and another conventional chest tube placed in the left pleural space. The patient also had a central line at the time of surgery. The pleuraflow system performed throughout its use and the incident occurred just before the planned removal of the pleuraflow system from the chest. Prior to the incident the nurse moved the patient from bed to a sitting position in a chair and then the patient was moved back to bed. Once the patient was back in bed, the nurse advanced the clearance wire and loop to the parked position inside the chest tube with no resistance to movement. Then when the nurse pulled the clearance wire and loop back out of the chest tube, the external and internal magnets decoupled from each other (magnetic safety release) and the nurse was unable to recouple the magnets and pull the clearance wire and loop back out of the chest tube. At that point the nurse pulled the pleuraflow system out as planned and noticed that the clearance wire loop was outside of the chest tube through one of the eyelets. The nurse reported seeing a small piece of tissue on the wire loop. After the chest tube was removed the patient was asymptomatic and x-ray was unremarkable. On (b)(6), 2015, postoperative day 2, the patient developed mild to moderate subcutaneous emphysema in the left upper chest and neck area. The subcutaneous emphysema was managed by the conventional chest tube that was originally placed in the left pleural space during the index surgery. The patient was transferred back to the hospital from where the patient had arrived for the urgent surgery on schedule, without a delay. At that time of transfer the patient did not experience postoperative complications. The operating surgeon suspected that the air leak was possibly caused by the clearance wire loop and the piece of tissue being a lung tissue. Two tissue samples were removed off the device and sent to a forensic pathology laboratory (forensic analytical sciences services, inc, (b)(4)) for analysis. Two pathologists reviewed h&e stained histology samples prepared from the tissue samples. The pathologist identified one sample as representing adipose tissue. The pathologist did not find any structures, which are clearly diagnostic of lung tissue. Taking into account the location of the chest tube in the mediastinum, i. E. , outside of the pleural spaces and the opinion of the independent forensic pathologist, we conclude that the incident is most likely not related to the pleauraflow system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008782989-2015-00003 |
| MDR Report Key | 5221488 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2015-11-13 |
| Date of Report | 2015-11-12 |
| Date of Event | 2015-09-09 |
| Date Mfgr Received | 2015-10-14 |
| Device Manufacturer Date | 2014-03-07 |
| Date Added to Maude | 2015-11-13 |
| 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 92806 |
| Manufacturer Country | US |
| Manufacturer Postal | 92806 |
| Manufacturer Phone | 7149165014 |
| Manufacturer G1 | XERIDIEM MEDICAL DEVICES |
| Manufacturer Street | 4700 SOUTH OVELAND DR. |
| Manufacturer City | TUSCON AZ 85714 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85714 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLEURAFLOW SYSTEM |
| Generic Name | OTK AND GBX |
| Product Code | OTK |
| Date Received | 2015-11-13 |
| Returned To Mfg | 2015-10-14 |
| Model Number | PF-28 |
| Lot Number | 8910-01 |
| Device Expiration Date | 2016-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLEARFLOW, INC. |
| Manufacturer Address | 1630 S. SUNKIST ST. SUITE E, ANAHEIM CA 92806 US 92806 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-13 |