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

Model Number	8700-0666
Medical Device Problem Codes	Device Issue (2379); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the zoll suk in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.Zoll personnel completed, on 02/19/2016, a follow-up training with the customer on the uses of the ivtm system.The patient experienced infusion of 750ml of sterile saline from the system into vasculature due to a leak in the system.The customer did not report any injury related to the infusion of saline.The patient died due to his clinical condition of encephalitis.Intravascular administration of ~1l of cold saline is a common practice in the patient's treatment and in agreement with a customer, was not a cause of the patient's death or any other serious injury.
Event or Problem Description
It was reported that during therapeutic treatment with the ivtm thermogard system a leak was observed.The treatment was on a male patient, (b)(6), weighing (b)(6) who was hospitalized to be treated for normothermia.The patient's temperature prior to ivtm therapy was 42.1 degrees celsius.There were no adjunct temperature management or relative procedures performed on the patient.The icy catheter was inserted by an experienced physician into the left femoral vein.The insertion was difficult, however it was made in one attempt.The dwell time the catheter was kept in the patient for 15 minutes.It was observed, after 2 minutes, that the saline bag was empty.No leaks were observed on the patient or on the bed.It was assumed that 750ml of saline solution went into the patient.It was reported that an air trap alarm sounded, bubbles were seen in the system, and the catheter was replaced; however the treatment was discontinued.It was reported that the patient expired as a result of his encephalitis.Reference: mfr 3010617000-2016-00166.
Additional Manufacturer Narrative
Suk (s/n (b)(4)) was returned to zoll (b)(4) on (b)(4) 2016 for evaluation.Investigation results as follows: the visual inspection of the returned start-up kit (suk) found no discrepancies or issue.The start-up kit was connected to a peristaltic pump.In doing so, no device leak paths were found.The returned suk was installed on a peristaltic pump for testing.Subsequent testing found no leaks or issues.The unit was connected to an ivtm system.The system ran on max cooling and max warming for approximately 30 minutes each run; no leaks observed.No additional issues were found.During start-up kit (suk) 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 (assembly flow and pressure test per - mpi02-046).The root cause for the reported user experience could not be confirmed; no leaks with suk were observed.A probable cause for the customer complaint was user error, due to a luer misconnection, resulting in saline fluid into the patient.As a remediation, re-training was performed for the customer in (b)(4) 2016.

• 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: 5502016
• Report Number: 3010617000-2016-00167
• Device Sequence Number: 330593
• Product Code: NCX
• UDI-Device Identifier: 00849111075329
• UDI-Public: 00849111075329
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K014241
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2016

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: 8700-0666
• Device Catalogue Number: 8700-0666-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/15/2016
• Supplement Report FDA Received Date: 04/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 150