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

Model Number	8700-0666
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	08/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A start-up kit (suk # 064427) was returned to zoll (b)(4) for evaluation.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for suk with lot number 064427.A visual inspection of the returned start-up kit (suk) found no visual discrepancies or issues.No issue or damage was observed in the tubing.The start-up kit was connected to a peristaltic pump.In doing so, no device leak paths were found.In-house catheter was connected to the returned suk and a peristaltic pump testing was performed and found no leaks or issues.The units (returned suk and in-house catheter) were connected to an ivtm system and ran on max cooling and max warming for approximately 30 minutes each run; no leaks were observed.Evaluation of the returned start-up kit (suk) found no discrepancies or issues which contributed to the reported problem.The customer reported issue could not be confirmed.Note, during start-up kit (suk) - standard manufacturing, 100% of the units are tested for pressure flow to ensure both the absence of pressure discrepancies throughout the device, and that all tubing locations are free of any leak paths.Only passing units are accepted and moved to the next process.
Event or Problem Description
It was reported that the suk pin-sized hole in tubing leaking and the liquid was found on the patient bed.There was no issue getting console started.A new start-up kit was replaced and the therapy was continued and completed.Additional information was received from medwatch stating that rn noted pt's bed linens were saturated.Upon inspection of the cool line tubing it revealed a crack in the tubing at the connection site to the actual quattro catheter.The original procedure was intended to maintain normothermia for traumatic brain injury.

• 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: 5988068
• Report Number: 3010617000-2016-00707
• Device Sequence Number: 40876
• Product Code: NCX
• UDI-Device Identifier: 00849111075329
• UDI-Public: 00849111075329
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K014241
• 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): 09/29/2016

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: 8700-0666
• Device Catalogue Number: 8700-0666-01
• Device Lot Number: 064427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2016
• Initial Report FDA Received Date: 09/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1