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

Model Number	CG-500D
Medical Device Problem Codes	Leak/Splash (1354); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the zoll catheter for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.Reference mfr # 3010617000-2017-01053 - (b)(4) - quattro catheter.
Event or Problem Description
A patient was hospitalized in icu and an ivtm was needed.A zoll quattro catheter placed a day before the patient was taken to cath lab.During procedure in the cath lab, the customer noted blood in the start-up kit (suk) and saline bag.The catheter was removed and the patient was placed on arctic sun.The catheter breach was likely caused by the procedure/pci.The customer was not supposed to be utilizing the quattro catheter, as they have not had their official 'go-live'.No known 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: 7109336
• Report Number: 3010617000-2017-01060
• Device Sequence Number: 18853556
• Product Code: NCX
• UDI-Device Identifier: 00849111075329
• UDI-Public: 00849111075329
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/12/2017

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?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 12/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1