MAUDE Adverse Event Report: ZOLL CIRCULATION, INC ZOLL IVTM ICY CATHETER; CENTRAL VENOUS CATHETER

Model Number	IC-3893
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the zoll catheter for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
On (b)(6) 2018 at 1 pm, the thermogard ivtm system was used for patient treatment.After 11 hours of running the thermogard ivtm system, it was observed that the saline fluid level had dropped quickly.The doctor removed the 1st catheter and found it had a leak.The doctor replaced the 1st catheter with a new catheter (2nd) and the system functioned properly.Around 1 am, the thermogard ivtm system alarmed and indicated that an air trap leak was at fault.The doctor and bme turned off the system and cleaned up all the moisture on the airtrap.After cleaning, the system was restarted again, but it did not function.However, the user stated that the system function properly at a later unspecified time.The user reported that the two catheters had a leak.One catheter leaked in one place and the other catheter leaked in two places.No further patient information was provided.No known impact or consequence to patient.Reference mfr reports: 3010617000-2018-00521 (2nd icy catheter) and 3010617000-2018-00522 (thermogard xp console).

• Brand Name: ZOLL IVTM ICY CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood avenue; san jose CA 95131
• MDR Report Key: 7489574
• Report Number: 3010617000-2018-00520
• Device Sequence Number: 160372
• Product Code: NCX
• UDI-Device Identifier: 00849111075510
• UDI-Public: 00849111075510
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2018

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: IC-3893
• Device Catalogue Number: 8700-0782-14
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 05/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1