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

Model Number	8700-0654
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The catheter associated with this complaint was not returned for evaluation.Since the device was not returned, an investigation could not be performed and a root cause was related to the leaking luers of the start-up kit (suk).In the case the device is returned, the complaint will be re-opened to perform an investigation.
Event or Problem Description
It was reported that customer placed a cool line catheter with the new orange zoll luers in a neuro patient ((b)(6) male patient weighing (b)(6) and 6' 2'' in height) to help maintain normothermia/fever control on (b)(6) 2016.The patient has a medical history of migraines and was diagnosed for non-traumatic intracranial hemorrhage.On (b)(6) 2016, nurse tried to hook the patient back up to the ivtm console after he returned from a procedure and found the orange luer to be hard to connect and then a steady stream of fluid coming from orange luer when it was hooked up.The nurse turned off the console.The clinical specialist confirmed that problem reportedly was occurring with the orange luer.It is unknown if the problem was with luers of catheter or start-up kit (suk).No harm had occurred to the patient.The physician removed the catheter and used cooling blankets to maintain normothermia.

• Brand Name: ZOLL IVTM COOL LINE CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 5926519
• Report Number: 3010617000-2016-00628
• Device Sequence Number: 605097
• Product Code: NCX
• UDI-Device Identifier: 00849111075046
• UDI-Public: 00849111075046
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2016

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: 8700-0654
• Device Catalogue Number: 8700-0654-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2016
• Initial Report FDA Received Date: 09/02/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 118