MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL IVTM SUK; CENTRAL VENOUS START UP KIT

Model Number	CG-500D
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The zoll start-up kit (suk) was returned to zoll on (b)(4) 2017 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.Reference ccr # (b)(4) - quattro catheter.
Event or Problem Description
A patient was hospitalized post cardiac arrest and an intravascular temperature management (ivtm) was needed.A zoll quattro catheter was inserted into the left femoral vein and the ivtm therapy was initiated at 11pm on (b)(6) 2017.The insertion was smooth.The patient's temperature prior to the ivtm therapy was 37.2 degree celsius.The target temperature on the console was 33 degree celsius.During therapy, an air trap alarm was noted.The attending nurse changed the saline bag and the air trap alarm was cleared.7.5 hours into the therapy, blood was noted in the start-up kit (suk).The catheter was replaced and therapy was resumed.No patient consequences were reported.

• Brand Name: ZOLL IVTM SUK
• Common Device Name: CENTRAL VENOUS START UP KIT
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 7026472
• Report Number: 3010617000-2017-00901
• Device Sequence Number: 1411015
• Product Code: NCX
• UDI-Device Identifier: 00849111075329
• UDI-Public: 00849111075329
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K014241
• 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): 11/13/2017

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?: No
• Operator of Device: No Information
• Device Model Number: CG-500D
• Device Catalogue Number: 8700-0666-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 11/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1