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..
[68976458]
This potential failure mode - clearance wire loop exiting through the proximal end of 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. Two potential failure modes could have caused or contributed to this incident. One, the operator who placed the device cut the chest tube too short. The second potential failure mode is that the clearance wire crossed into the chest tube. The probability of the first failure mode is very low since the operators are trained on using the device and have been using it on an ongoing basis. The second failure mode is more likely. For this failure mode to happen, one must apply significant force to both the chest tube with the clearance wire held inside and to the guide tube in opposite directions, simultaneously. The chest tube might have been clamped with the clearance wire inside the chest tube when the patient was transported from the cardiac surgery operating room to the cardiology icu. Another possibility is that the nurses applied force on the chest tube with the clearance wire inside while stripping and milking it along with the other conventional chest tubes as the patient was reported to have bled profusely in the icu after the first revision surgery. The protocol nurses use to manage chest tubes at this hospital is as follows. While the patient stays in the icu they strip every 15 min for the first 6 hours, then every 30 to 60 minutes as needed. As the lot number of the device used is unknown, manufacturer is unable to conduct a review of the device history record. 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. The cardiology icu staff never saw the pleuraflow system and was not trained on the use of the pleuraflow system. Further, cardiology icu staff informed the manufacturer's representatives that they were unaware of the pleuraflow system and did not differentiate it from the conventional chest tubes. Manufacturer does not have any information that the nurses actuated the pleuraflow system or even realized that it was there. The rate of this failure mode - clearance wire exiting the proximal end of the chest tube - is 111 in a million. The previous 2 incidents occurred in 2012 and were due to user error by way of having cut the chest tube shorter than indicated. Device was discarded by user and is not available for failure analysis. Reported failure most likely resulted from the cardiology icu nurses using a device that they have encountered for the first time without introduction and without training. This most likely resulted in 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. Device discarded at the event site.
Patient Sequence No: 1, Text Type: N, H10
[68976459]
Date of operation: (b)(6) 2017. Procedure: emergency surgery was done in the cardiac surgery operating room to patch the pericardium of a patient who had an ecmo and impella device placed earlier by an interventional cardiologist and which resulted in pericardial tamponade. After the conclusion of the emergency surgery, the cardiac surgeon placed a pleuraflow system and other conventional chest tubes and the chest was left open due to bleeding. Patient was transferred from the cardiac surgery operating room back to the cardiology icu, located in a separate building. Patient bled profusely in the cardiology icu after the emergency surgery and nurses stripped and milked the chest tubes to keep them open. The cardiology icu staff never saw the pleuraflow system and was not trained on the use of the pleuraflow system. Further, cardiology icu staff informed the manufacturer's representatives that they were unaware of the pleuraflow system and did not differentiate it from the conventional chest tubes. Manufacturer does not have any information that the nurses actuated the pleuraflow system or even realized that it was present. The following day, (b)(6) 2017, morning, a cardiac surgeon re-operated the patient in the cardiology icu for revision/bleeding. During this operation, the cardiac surgeon noticed that the clearance wire and loop extended out of the proximal end of the chest tube. The surgeon removed the clearance wire and left the chest tube.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008782989-2017-00003 |
| MDR Report Key | 6368855 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2017-03-01 |
| Date of Report | 2017-02-28 |
| Date of Event | 2017-01-12 |
| 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 |
| 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 |