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

Model Number	IC-3893AE
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of icy catheter leak was confirmed during functional test.A water emission/leak was observed at the distal luered tubing during lumen crosstalk test.Visual examination of the returned catheter was performed and found no physical damage.Functional testing of the returned catheter was performed.All infusion ports and extension tubes were flushed without resistance.The catheter was connected to a pressurized inflation device for one minute, a water emission/leak was observed at the distal luered tubing during lumen crosstalk test.Thus, confirming the reported complaint.During manufacturing all icy catheters are 100% inspected for leaks by subjecting them to pressure testing.Only units that passed are moved to the next process.Probable causes for the reported complaint can be a latent material defect.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for icy catheter with lot number 82505.
Event or Problem Description
During a (b)(6) female's ivtm therapy, customer reported that the patient did completed a 24 hours of cooling with no issue but during a couple of hours into warming phase, the hospital nurse noticed saline bag was low, almost empty.Customer stopped treatment, removed the icy catheter (lot #82508) and patient was placed with surface cooling to continue with treatment.According to customer, saline fluid was not found outside of the console, on the floor or patient's bed.Console did not set off alarm and air trap was still full of fluid.No known impact or consequence to patient information was available.

• Brand Name: ZOLL IVTM ICY CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 8363872
• Report Number: 3010617000-2019-00152
• Device Sequence Number: 19313725
• Product Code: NCX
• UDI-Device Identifier: 00849111075077
• UDI-Public: 00849111075077
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2019

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: 8700-0695-40
• Device Lot Number: 82505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 02/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR