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

Model Number	8700-0666
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product in complaint was returned to zoll on 10/31/2016 for investigation.However, investigation is still in progress.A supplemental report will be filed once investigation has been completed.
Event or Problem Description
It was reported that a female patient was admitted into the hospital for post- arrest hypothermia.The cooling procedure started on (b)(6) 2016 and stopped on (b)(6) 2016.There were no other temperature management procedures performed on the patient.An icy catheter was inserted in the right femoral vein.There were no issues during set up and priming.Before connecting the suk to patient, it was immediately noticed that the suk orange luer male connector was found to be broken.The suk was removed and another suk was used.It was able to connect to system successfully.The therapy was continued and completed.Per reporter, the family made the decision to continue with comfort measures only and withdraw care when she did not wake up after completion of treatment.The patient expired on (b)(6) 2016.The cause of death was not provided and the death was not attributed to the device.No other information was provided.
Additional Manufacturer Narrative
Start-up kit (suk # (b)(4)) 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 suk was performed and found the male and female luer lock connections observed to be damaged.Further investigation found that the male luer broken off into the female luer; thus confirming the reported complaint.No leak testing was performed based on the condition of the suk luer connectors.Evaluation of the returned start-up kit (suk) confirmed the customer reported issue as broken male luer connector.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.

• 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: 6080559
• Report Number: 3010617000-2016-00787
• Device Sequence Number: 13640091
• 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: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2016

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/31/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2016
• Supplement Report FDA Received Date: 11/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1