MAUDE Adverse Event Report: ALUNG TECHNOLOGIES, INC HEMOLUNG 15.5 FR JUGULAR CATHETER TRAY KIT; HEMOLUNG CATHETER

ALUNG TECHNOLOGIES, INC HEMOLUNG 15.5 FR JUGULAR CATHETER TRAY KIT; HEMOLUNG CATHETER

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Device Problem Fluid/Blood Leak (1250)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)

Event Date 10/19/2018

Event Type Injury

Manufacturer Narrative

Event Description

Alung was notified of a serious deterioration in the state of health which resulted in a medical intervention.After hospital staff rolled the patient they noticed a large amount of bleeding from the insertion site.The research nurse and doctor were called in immediately from the next door room.After closer inspection they noticed the bleeding was coming from a crack in the ij catheter.Therapy was stopped and the lines clamped.Pressure was applied to the insertion site.The patient became tachycardia and hypotensive and the patient was treated with fluid, blood, and metaraminol.The decision was made to remove lin, and direct pressure applied for 30 minutes as per protocol.No evidence of bleeding from insertion site, and there was a suture applied.The patient was monitored for further bleeding per protocol.The catheter has been retained for inspection by alung.The site couldn't remember if the hemolung was alarming due to the emergent situation.The patient is stable after receiving 2 units blood and drugs to increase blood pressure.

Event Description

Manufacturer Narrative

Event Description

Manufacturer Narrative

Alung was notified of a serious deterioration in the state of health which resulted in a medical intervention.The research nurse and doctor were called in immediately from the next door room.After closer inspection they noticed the bleeding was coming from a crack in the ij catheter.Therapy was stopped and the lines clamped.Pressure was applied to the insertion site.The patient became tachycardia and hypotensive and the patient was treated with fluid, blood, and metaraminol.The decision was made to remove line, and direct pressure applied for 30 minutes as per protocol.No evidence of bleeding from insertion site, and there was a suture applied.The patient was monitored for further bleeding per protocol.After closer inspection they noticed the bleeding was coming from a crack in the ij catheter.There was a medical intervention that was required as a result of the blood loss and drop in blood pressure.The patient was given 2 units of blood and drugs to increase his blood pressure due to the loss of blood.On 22/10/2018, alung clinical manager debbie bannister spoke to the research nurse, who confirmed the catheter serial number is s035117.The patient remains stable with no further issues related to the issue or sudden end of therapy.Debbie informed the research nurse that the explant kit is on its way and an engineer will be downloading the datalog and test the controller when the controller is available.Follow up 11-20-18: alung clinical manager debbie bannister conducted on site meetings with john smith and michael whitehorne.Neither john nor michael could confirm exactly where the catheter was sutured as they didn't see the catheter securement during therapy.However, after discussions with the doctor who inserted the catheter, john said it was sutured nearer the insertion point, round the reinforced coil section, not in the suture groove or near the y section.The doctor told him he didn't suture around the lumen where the issue occurred and that if he were to have sutured one of the lumens it would have been the blue not the red one due to its position.In addition, micheal whitehorne showed debbie the catheter before he packed it to return to alung.He commented that it looked like the catheter was sutured around the reinforced coil section (not near the issue) as he could see an indentation in the coil.He was unable to ascertain whether there had been any pressure applied to the catheter during the procedure to roll the patient just prior to the issue.John confirmed that the patient is continuing to recover well.A review of the collected data log indicated that therapy ran well, without critical errors or clinically significant alarms.It should be noted there was a high blood flow alarm at 11:31 on 10/19/2018.Blood flow increased from 460 ml/min up to 620 ml/min).At this time, the data log indicates the user immediately started decreasing the sweep gas flow and rpm (blood pump speed).The blood pump was turned off at 11:39.This is believed to be the when the site discovered the bleeding/catheter issue.The high blood flow alarm indicates the controller is noted to be functioning as intended.Alung internally decided to test the controller post-therapy out of an abundance of caution to demonstrate that the controller was functioning as intended.It is noted that during the testing of the controller, post-therapy, there was a failure during the controller test relative to the battery voltage reading.The battery voltage, as documented in section 6.63 of qsd 540-017_r18, is 24.9.The test indicates that the highest voltage observed is >/= 27.5.Alung service department analyzed the failed result.It is noted that the controller was functioning as intended during the related patient therapy (16/10/2018-19/10/2018).The analysis concluded that on 16-oct-2018 at 13:31:38 the log file shows the voltage at 27.8, rising to 28.0 shortly after, indicating the controller was working as expected.Alung is taking the following actions: 1.Continue discussions with the physician and hospital staff to determine if there is any additional information relevant to the case.Completed 2.Alung will collect the controller data log and analyze the system performance during the case therapy.Data log collection completed anf controller test completed 3.Complete explant analysis of the hemolung catheter.Completed.4.Alung will follow-up or close the case in 30 days.Completed.Alung's device analysis results: alung was notified of a serious deterioration in the state of health which resulted in a medical intervention.There was bleeding coming from a crack in the ij catheter.As a result of the cracked catheter, a medical intervention was required due to patient's blood loss and drop in blood pressure.The patient was given 2 units of blood and drugs to increase his blood pressure due to the loss of blood.It should be noted that the patient recovered from the incident.Alung performed an analysis of the catheter in conjunction with the catheter manufacturer, nordson medical.The jugular catheter was returned to alung, with a ripped infusion cannula.The rip was located where the infusion cannula meets the bifurcation.The rip was in the wire reinforced part of the cannula.The cannula tore on the middle of the y of the bifurcation and only a small portion of material remained holding the catheter together.The point that was still attached contained a single strand of wire.This wire was continuous with the rest of the wire coil on both sides of the rip.Narrowing of the tubing was noted on the infusion cannula near the rip, potentially a result of some stretching force.A significant amount of blood was left in the catheter after use and had clotted.The catheter was not flushed or fixed prior to return, and multiple weeks went by before the device was shipped, so clotting in the device cannot be analyzed.The drainage basket and infusion port at the end of the dual lumen catheter appeared intact, presenting no signs of damage.The wire reinforced tubing between the ports and bifurcation were intact, except for some deformation approximately one inch from the bifurcation.It could not be determined what caused this, but it did not appear to occlude the cannula.The bifurcation/drainage cannula joint appeared intact.Apart from the tear, the rest of the infusion cannula was intact.Both connectors for blood tubing to the cartridge appeared intact as well.As such, alung was unable to identify a specific failure mode that caused the cannula tear.The catheter was fixed with excell fixative and sent to the catheter manufacturer, nordson medical, for further analysis.Nordson medical conducted a dhr review for the final assembly cannula and nothing unusual was found during the documentation review.There were no non-conformance reports associated with the catheter lot.It should be noted that the dhr contains a temporary deviation to use a similar polyethylene bag, but seven inches longer, while the standard bag was not available.These polyethylene bags are used for storage prior to final assembly and the deviation should have had no impact on the failure reported.In addition, records for sub-assembly lots and incoming lots were reviewed and nothing unusual was found and there were no non-conformance reports or deviations associated with any of the lots reviewed by nordson.As previously stated, the catheter unit was received at nordson medical's huntington beach facility.The part was evaluated and it was found that cannula taper of the infusion cannula has signs of compression that is deforming the taper of infusion cannula body.No signs of damage or cuts caused during molding or assembly operations were noted.Uv bonding adhesive confirmed to be present and properly cured.The spring did not break, however, it does show signs of deformation due to handling.It is unknown at this point if this was caused before or after the event.Likewise, the body of the cannula presented apparent clamping damage which is presumed there was a clamping post failure to stop bleeding.Nordson also conducted further analysis at their facility.Scrap part was pulled to fail from reported section using the same method described on product validation.The results showed an average of 40 lbf to break the part on the reported section.As such, the results and failure mode remain consistent with the results obtained during product validation and are within the acceptance criteria defined in the validation protocol.In addition, pull testing was performed using a 90 degree angle on the cannula and connector.The results were of similar failure mode to the one reported.A pull force to break resulted in over 30 lbf.After initial investigation and testing, nordson medical concluded that it is unlikely that the failure reported was related to the manufacturing process or a failure of the product to meet customer specifications.No further investigation or action is deemed necessary at this point.This is the first time this failure was reported to nordson by a customer and at this point the cause remains unknown and the case isolated.Nordson has closed their investigation and the infomation will be captured for trending purposes.The catheter is being returned to alung.The evaluation of the catheter conducted by both alung and nordson were unable to determine the cause of the catheter tear.There were no abnormalities identified by nordson during the manufacturing process or in their documentation review.Through communication with the hospital, it was noted that the catheter was not sutured at the site of the tear, and there were no known occurrences during therapy that could have contributed to the catheter tear.As such, alung concludes this is an isolated incident which has no impact to product or the public health.Alung will continue to monitor the occurrence of this event.No further action is required.It should be noted that a review of the collected data log indicated that therapy ran well, without critical errors or clinically significant alarms.Also, it was noted in the follow up report on 11-20-18 there was a failure on the initial controller test.The controller was retested on 11-26-18 and it passed all tests.It should be noted that alung internally decided to test the controller post-therapy out of an abundance of caution to demonstrate that the controller was functioning as intended and this has no impact on the catheter tear.

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Brand Name

HEMOLUNG 15.5 FR JUGULAR CATHETER TRAY KIT

Type of Device

HEMOLUNG CATHETER

Manufacturer (Section D)

ALUNG TECHNOLOGIES, INC

2500 jane street

suite 1

pittsburgh PA 15203

MDR Report Key

8023347

MDR Text Key

125605607

Report Number

3009763347-2018-00003

Device Sequence Number

Product Code

DQR

Combination Product (y/n)

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

company representative

Type of Report

Initial,Followup,Followup

Report Date

10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

No Information

Was Device Available for Evaluation?

Device Returned to Manufacturer

Date Returned to Manufacturer

12/14/2018

Initial Date Manufacturer Received

10/19/2018

Initial Date FDA Received

10/31/2018

Supplement Dates Manufacturer Received

10/19/2018
10/19/2018

Supplement Dates FDA Received

11/20/2018
12/18/2018

Is This a Reprocessed and Reused Single-Use Device?

Patient Sequence Number

Patient Outcome(s)

Required Intervention;

MAUDE Adverse Event Report: ALUNG TECHNOLOGIES, INC HEMOLUNG 15.5 FR JUGULAR CATHETER TRAY KIT; HEMOLUNG CATHETER

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