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 2017-03-09 for PLEURAFLOW SYSTEM PF-28 manufactured by Clearflow, Inc..
[69757892]
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. It is not clear if the nurse followed the actuation schedule per the ifu. Not actuating the device per recommendation might lead to blood coagulating in the chest tube, hindering movement of the clearance wire inside the chest tube. 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 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 attempts to pull the clearance wire that has been immobile inside the chest tube for a few hours, out of the chest tube with force. Photos of the device in the patient were provided by the hospital. Those show the proximal 1-2 cm of the stop wire projecting into the chest tube and the clearance wire kinked a few centimeters farther towards the proximal end. 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 moving past the proximal 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 and during the first hour in the cvicu. 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 the 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 retrieved and a failure analysis is in process. 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. A definite root cause is unknown. No injury to patient.
Patient Sequence No: 1, Text Type: N, H10
[69757893]
Date of operation: (b)(6) 2017. 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. It is not clear how long it took between the last actuation in the operating room and the first actuation in the cvicu. The nurses reported that they experienced decoupling of the external magnets from the internal magnets while the clearance wire was in the parked position one hour after the patient was admitted to the icu. They stopped actuating and 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 monday (b)(6) 2017, the icu head nurse reported that the proximal stop wire was around one centimeter inside the distal portion of the chest tube. The proximal stop wire prevents the clearance wire and loop from moving past the proximal end of the chest tube. The nurse pulled the clearance wire out of the chest tube and left the chest tube connected to the guide tube and the guide tube connected to the drainage canister.
Patient Sequence No: 1, Text Type: D, B5
[73920265]
The device was returned for evaluation. The device was first inspected for any molding defects, short fills, voids, and/or flow lines, and none were observed. Measurements of the device were taken. The chest barb and the drain barb were within specification. The length and height of both the proximal and distal stop wires were within specification. The acute and obtuse angles of the distal stop wire were within specification. The acute and obtuse angles of the proximal stop wire were found to be out of specification due to damage. Chest tube eyelets were all within specification. The clearance wire was kinked at an angle of >45 degrees approximately 3. 81 cm towards its proximal end while the chest tube and clearance wire were in the patient. The reported incident was confirmed. Damage to the proximal stop wire was observed, which caused the acute and obtuse angles to be out of specification. The proximal stop wire was damaged during use. The damage to the proximal stop wire most likely led to the reported malfunction. Findings were reviewed with the surgeons and the use of the device is on hold pending the retraining of operating room and icu personnel. The stop wire, which prevents forward movement of the clearance wire beyond the chest barb into the distal portion of the chest tube, moved past the chest barb into the distal portion of the chest tube. 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. None of the four incidents resulted in patient injury. None of these incidents were confirmed to have been attributed to the manufacturing process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008782989-2017-00004 |
| MDR Report Key | 6393993 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2017-03-09 |
| Date of Report | 2017-03-09 |
| Date of Event | 2017-02-13 |
| Device Manufacturer Date | 2015-05-01 |
| Date Added to Maude | 2017-03-09 |
| 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 CA 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 | 2017-03-09 |
| Returned To Mfg | 2017-02-28 |
| Model Number | PF-28 |
| Catalog Number | PF-28 |
| Lot Number | 916204 |
| Device Expiration Date | 2017-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2017-03-09 |