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

Model Number	ICY-3893AE
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2016
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.Since the device was not returned, this complaint will be processed for closure.In the case the device is returned, the complaint will be re-opened to perform an investigation.Note: the infusion of a 500 ml bag of saline would not present a serious injury to a person with functioning fluid balance physiology.The response would be the loss of the fluid via increased urine output.Not returned to manufacturer.
Event or Problem Description
An icy catheter was placed in a patient for the therapy of hypothermia.At an unspecified time later, it was noticed that there was a leak and approximately 2 liters of saline was emptied into the patient.There was no patient injury or death reported.The catheter was discarded by the customer.Multiple attempts were made to obtain additional information; however, were unsuccessful.No other information was provided.

• Brand Name: ZOLL IVTM ICY CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 6286951
• Report Number: 3010617000-2017-00072
• Device Sequence Number: 19024774
• Product Code: NCX
• UDI-Device Identifier: 00849111075077
• UDI-Public: 00849111075077
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 01/30/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: ICY-3893AE
• Device Catalogue Number: 8700-0657-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2017
• Initial Report FDA Received Date: 01/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1