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

Model Number	8700-0660
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	11/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in complaint will not be returned for investigation.Therefore, a physical investigation will not be performed.Note:based on the information provided that the patient experienced a cardiac arrest due to heroin overdose.The patient was resuscitated, underwent therapeutic hypothermia.However;the patient never recovered and eventually expired.Per reporter, the patient's death was attributed to the patient's clinical condition of heroin overdose that led to cardiac arrest and the death was not attributed to the device.
Event or Problem Description
It was reported that the patient was hospitalized for post cardiac arrest and required therapeutic hypothermia.The quattro catheter was placed in a patient.During maintenance phase it was found that the saline bag ran dry blood return in line.It was assumed that the catheter was leaked.The system was switched in standby mode and the catheter was kept inside the patient for central access use.The blanket was performed on the patient instead.Additional information was received that the patient had expired.Per reporter, the heroin overdose that led to cardiac arrest and the death was not attributed to the device.

• Brand Name: ZOLL IVTM QUATTRO CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 6199863
• Report Number: 3010617000-2016-00937
• Device Sequence Number: 623583
• Product Code: NCX
• UDI-Device Identifier: 00849111075121
• UDI-Public: 00849111075121
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/22/2016

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: 8700-0660
• Device Catalogue Number: 8700-0660-40
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2016
• Initial Report FDA Received Date: 12/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1