MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL IVTM SOLEX CATHETER; CENTRAL VENOUS CATHETER

Model Number	8700-0671
Medical Device Problem Codes	Leak/Splash (1354); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The zoll catheter in complaint was returned to zoll on 03/25/2016 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.
Event or Problem Description
It was reported that upon starting the solex catheter line, it began to fill with blood as the saline began to circulate.The patient was female, (b)(6) and was hospitalized for head injury and neuro fever.Blood coagulopathy results were available prior to initiation of therapy.A zoll solex catheter was inserted into the left subclavian vein, it is unknown if the insertion was difficult or smooth.The dwell time the catheter was 0-1 hours when the leak was discovered.The blood was observed circulating from the catheter and in the start-up-kit.The blood circulated within the circuit and began filling the saline priming bag.The system alarmed and went into standby mode.The system was stopped and the tubing clamped and removed from the catheter.There were no changes to the patient's vital signs or level of consciousness.To troubleshoot the issue, saline was inserted into the removed catheter it was reported that a leak was observed in the proximal end of the serpentine balloon.The treatment with the solex catheter was stopped immediately and the catheter was removed.They replaced it with a standard zoll catheter.The patient did no experience any adverse effects from this event.A chest x-ray was performed to assess for any injury, which confirmed no injury to the patient.Patient's vital signs remained stable before, during and after this event.No additional information was provided.
Additional Manufacturer Narrative
Two solex catheters (s/n (b)(4)) were returned to zoll (b)(4) on 03/25/2016 for evaluation.A visual inspection found no visual discrepancies or issues.All lumens flushed as intended.No leaks were noticed during flushing for both catheters.The returned catheters were connected to a pressurized inflation device.The device was pressurize up to 100psi, and a leak path was identified at the heat exchange membrane (at radiopaque marker) near proximal end of one catheter, while no leak was noted with another catheter.A tear was noted near the radiopaque marker for the leaked catheter.Following the test, all balloons deflated successfully without any issues.Device history record was reviewed for balloon bonding lot no 51660 found no nonconformities with the lot.Evaluation of the returned devices confirmed the customer reported issue as one solex catheter leaked at the heat exchange membrane near proximal end of catheter.The probable cause for the customer reported issue was due to user mishandling, including, but not limited to damage during device operation.

• Brand Name: ZOLL IVTM SOLEX CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 5546255
• Report Number: 3010617000-2016-00221
• Device Sequence Number: 331703
• Product Code: NCX
• UDI-Device Identifier: 00849111075152
• UDI-Public: 00849111075152
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K081936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8700-0671
• Device Catalogue Number: 8700-0671-01
• Device Lot Number: 56192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2016
• Supplement Report FDA Received Date: 06/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 70