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	03/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the zoll catheter in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
It was reported that during patient treatment a leak was observed after 4 days.The patient was female, (b)(6) who was hospitalized for a head injury and neuro fever.The patient's history included sah (subarachnoid hemorrhage) s/p ruptured aneurysm and cardiac arrest.Blood coagulopathy results were available prior to initiation of therapy.The zoll ivtm catheter was placed into subclavian vein and it is unknown if insertion was difficult or smooth.The patient temperature before therapy was 36 degrees celsius.The desired target temperature for the patient was 37 degrees celsius.The target temperature set point on the console was also 37.0 degrees celsius.Rate of cooling/warming was 0.2 degrees celsius.The bladder temperature probe was performed on the patient.The dwell time of the zoll catheter at the time of the observed leak, was 4 days.At this time the staff observed fluid leaking from the insertion site.The fluid leaking was observed immediately after the morning ct scan.However it appeared to have been leaking since the night before.There was a piece of gauze located under the dressing that was oozing.The amount of saline in the bag was at the correct level and balloon was not noted to be leaking.It was noted that the insertion site was bulging while propofol was being infused.The iv infusions were stopped however the treatment was continued for a short period.Within a few hours the solex was removed and replaced with a zoll icy catheter in the femoral vein and the treatment was continued.The patient was also on the arctic sun cooling device, both being used at the same time.The patient's health status at the time of the report was improving.No additional information was provided.Note: training was completed one week prior to this event.Zoll clinical specialist will discuss follow up training, with the customer.

• 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: 5546253
• Report Number: 3010617000-2016-00223
• Device Sequence Number: 13609361
• 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
• Report Date (Section B): 04/04/2016

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: 51660
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2016
• Initial Report FDA Received Date: 04/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 90