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

Model Number	8700-0782-01
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	01/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported icy catheter leak was confirmed.A water emission/leak was observed at the proximal luered tubing during the functional leak test.Visual examination of the returned catheter was performed and found no physical damage to the catheter.Balloons were covered in dried blood.Functional testing of the returned catheter was performed.All infusion ports and extension tubes were flushed without resistance, except the distal port was clogged with blood.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 luered tubing during lumen crosstalk test.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.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 previous history of complaint reported for a catheter with a lot number 88113.
Event or Problem Description
It was reported that during patient therapy with the thermogard tgxp, it was observed two bags of saline had emptied.The patient was inserted with an icy catheter through the femoral.After inspection, the user did not observe any leak near the console or around the patient.No alarm was noted on the console.The catheter leak was suspected.No consequences or impact to patient.

• Brand Name: ZOLL IVTM ICY CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 8476433
• Report Number: 3010617000-2019-00248
• Device Sequence Number: 1628977
• Product Code: NCX
• UDI-Device Identifier: 00849111075237
• UDI-Public: 00849111075237
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K770977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/02/2019

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: No Information
• Device Model Number: 8700-0782-01
• Device Catalogue Number: 8700-0782-01
• Device Lot Number: 88113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1