MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2017-03-01 for PLEURAFLOW SYSTEM PF-28 manufactured by Clearflow, Inc..
[68977783]
The ifu recommends actuating the device every 15 minutes during the first eight hours after surgery to minimize buildup of clot inside the chest tube. The downtime between the last actuation in the operating room and the first actuation in the cvicu may be significant, leading to blood coagulating in the chest tube and hindering movement of the clearance wire inside the chest tube. Indeed, the nurses noted that the clearance wire could not be advanced to the parked position and remained 3-4 centimeters away from the parked position. This potential failure mode - magnets migrating into the chest tube - is identified in the product fmea. This failure mode is mitigated to the lowest risk by design of the product, verification and labeling. For the internal magnets to enter the chest tube, one must apply significant force to both the chest tube with the clearance wire stuck inside and to the guide tube in opposite directions, simultaneously. This implies the possibility that the clearance wire was clamped as part of (i) transporting the patient; (ii) attempting to pull the clearance wire that has been immobile inside the chest tube for a couple of days out of the chest tube with force. Components used to manufacture the devices from this lot passed receiving inspection and met the design specs. Components had certificates of conformance stating that the components and materials met specifications. Each unit is actuated during the assembly process to verify that its performance meets specifications. By design, the proximal stop wire is larger in size than the inner diameter of the chest barb. This design feature prevents the clearance wire and loop from slipping past the chest barb into the distal end of the chest tube. Instructions for use state that: "if the internal and external magnets become uncoupled, advance or retract the external shuttle over the internal magnet to recouple the magnets. Retaining elements set on the internal magnets will keep the internal magnets and guide wire from exiting the guide tube, thus encouraging recoupling of the magnets. If after several attempts the magnets remain uncoupled, the pleuraflow guide tube may be disconnected from the pleuraflow chest tube. The chest tube may then be connected to the drainage tubing and canister in the standard fashion. " nurses did not follow the recommendation copied above from the ifu. The nurses were not trained on how to troubleshoot the system. The rate of this failure mode is 148 in a million. This failure mode occurred for the first time at one hospital over a span of four weeks and involved four devices used in four patients. The product functioned as intended in the operating room. The first problem reported by the cvicu nurses was decoupling of the external and internal magnets with the clearance wire inside the chest tube. Decoupling, also termed magnetic safety release, is a design safety feature that activates when resistance to wire movement inside the chest tube exceeds the force required to decouple the external magnets from the internal magnets. Decoupling limits the ability of the device to push or pull tissues in case the clearance wire loop exits the chest tube. The protocol nurses use to manage chest tubes at this hospital is as follows. While the patient stays in the cvicu they strip every 15 min for the first 6 hours, then every 30 to 60 minutes as needed. They use a device called a roller clamp to strip chest tubes. Prior to this incident, a clearflow representative witnessed that when decoupling persisted, the nurses used the roller clamp to strip the inner magnets through the guide tube and pull a clearance wire out of the chest tube. This was their approach to troubleshoot the problem. This maneuver could have damaged the clearance wire, stop wires and inner magnets resulting in some structural changes that could result in the described failure mode. Device was discarded by user and is not available for failure analysis. The failure could be associated with users' failure to operate the device according to the recommendations in the ifu leading to user error or misuse.
Patient Sequence No: 1, Text Type: N, H10
[68977784]
Date of operation: (b)(6) 2017 in the afternoon. Patient suffered a stroke during surgery prior to placement of the pleuraflow system. One pleuraflow system was placed in the anterior mediastinum and the patient was transferred to the cardiac surgery icu. Per ifu, the device was actuated in the operating room after it was inserted. Immediately after the patient was admitted to the cvicu, the nurses actuated the device and experienced decoupling of the external magnets from the internal magnets while the clearance wire was inside the chest tube 3-4 cm away from the parked position. It is not clear how long it took between the last actuation in the operating room and the first actuation in the cvicu. Nurses tried recoupling the external and internal magnets various times and each of these attempts failed. Since they were unable to pull the clearance wire out, they left the clearance wire inside the chest tube. Decoupling, also termed magnetic safety release, is a design safety feature that activates when resistance to wire movement inside the chest tube exceeds the force required to decouple the external magnets from the internal magnets. Decoupling limits the ability of the device to push or pull tissues in case the clearance wire loop exits the chest tube. On sunday (b)(6) 2017 (day 2 post op) and again on monday afternoon, (b)(6) 2017, the patient was transported from the icu to the ct suite for ct scanning because of neurological complications from emboli originating from a calcified aortic root during surgery. These two transports involved moving the patient from the cvicu bed onto a stretcher, moving patient into a van, driving from the building where the cvicu is located to another building where imaging was done, moving the patient out of the van to the ct suite. Moving the patient from the stretcher onto the ct table, adjusting the patient on the ct table, securing iv lines, performing the scan and then repeating the sequence of transporting the patient from the ct suite back to the cvicu. During both transports the clearance wire was left inside the chest tube 3-4 cm away from the parked position. Additionally, the cvicu nurse reported that the patient was sat up on the side of the bed as part of therapy. During that time, the clearance wire remained inside the chest tube. This was contrary to recommendations in the ifu. On (b)(6) 2017 afternoon (day 3 post op), a nurse noticed that the pleuraflow inner magnet moved into the pleuraflow chest tube. The device is designed to prevent the magnets from moving into the chest tube. This failure causes the clearance wire loop to extend beyond the proximal end of the chest tube into the chest. When they looked back at the ct taken a day before they could see that the clearance wire and loop extended out of the proximal end of the chest tube. A surgeon withdrew the clearance wire by cutting the pleuraflow chest-tube a few cm and pulling the wire easily out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008782989-2017-00001 |
| MDR Report Key | 6368673 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2017-03-01 |
| Date of Report | 2017-02-28 |
| Date of Event | 2017-01-29 |
| Device Manufacturer Date | 2014-06-05 |
| Date Added to Maude | 2017-03-01 |
| 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 | 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 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 | 2017-03-01 |
| Model Number | PF-28 |
| Catalog Number | PF-28 |
| Lot Number | 896102 |
| Device Expiration Date | 2017-01-31 |
| Operator | HEALTH PROFESSIONAL |
| 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 92806 US 92806 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-01 |