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

Model Number	IC-3893AE
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The zoll icy catheter was not returned to zoll for evaluation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
The patient was hospitalized and underwent ivtm therapy.A zoll icy catheter was inserted into the patient's femoral vein and the target temperature was set to 36 °c.Four hours after the catheter placement, the customer reported that the 500ml bag of saline had emptied.There was no fluid observed on the patient's bed or the floor.The catheter leak and 500 ml of saline infusion was suspected.The catheter was not replaced, however, specifics of the alternative therapy were not disclosed.No consequences or impact to patient.
Additional Manufacturer Narrative
The reported complaint of the icy catheter leak was confirmed.A water emission/leak was observed at the proximal luer tubing during the lumen crosstalk test.Probable causes for the reported complaint can be a latent material defect.A visual examination of the returned catheter was performed and found no physical damage to the catheter.There was a blood residue on the balloons and inside all lured tubing.Functional testing of the returned catheter was performed.All infusion ports and extension tubes were flushed without resistance.During functional testing, the catheter was connected to a pressurized inflation device for one minute, no leak was observed on the balloons.However, a water emission/leak was observed at the proximal lured port during the lumen crosstalk test.It is unlikely that the defective catheter was shipped.During manufacturing, all catheters are 100% inspected for leaks by subjecting them to pressure testing.Only units that passed are moved to the next process.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for a catheter with a lot number 143208.

• Brand Name: ZOLL IVTM ICY CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• MDR Report Key: 10215891
• Report Number: 3010617000-2020-00646
• Device Sequence Number: 2668940
• Product Code: NCX
• UDI-Device Identifier: 00849111075107
• UDI-Public: 00849111075107
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2020

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: IC-3893AE
• Device Catalogue Number: 8700-0657-40
• Device Lot Number: 143760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1