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

Model Number	IC-3893
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	10/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the icy catheter for investigation.A follow-up report will be submitted when the product is returned and investigation has been completed.
Event or Problem Description
During the maintenance phase of the ivtm treatment, the thermogard xp ivtm system generated "air trap" alarm and the user noticed empty saline bag.The user replaced the saline bag to continue the patient treatment.After 2 hours, the ivtm system generated "air trap" alarm and the user noticed empty saline bag again.There were no traces of saline on the floor or on the bed.The user flushed the in port luer with 5 ml of saline and observed blood tinge in the start-up kit (suk) tubing.Suspecting icy catheter balloon leak.The user switched to blankets for temperature management and continued to use the catheter for medication administration.Per user, the catheter insertion was difficult with blood returning into the catheter.Per user, the console maintained target temperature for the whole duration and no device malfunction was reported on the ivtm console.No patient consequence was reported.
Additional Manufacturer Narrative
The reported complaint of "the icy catheter (lot no 95695) balloon leak" was confirmed during the functional testing of the returned catheter.A pinhole leak was observed at the middle of the medial balloon.The probable root cause for the reported complaint could be due to a latent material defect.Upon visual inspection, no physical damage was observed.Noticed dried blood residue on the balloons and on the distal and proximal lured tubing's.During functional testing, all lumens were flushed without resistance.The catheter was connected to a pressurized inflation device.Immediately upon pressurizing the catheter, a pinhole leak was observed at the middle of the medial balloon.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 information related to the reported complaint and there was no previous history of complaint reported for icy catheter with lot no 95695.

• 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: 9306203
• Report Number: 3010617000-2019-00998
• Device Sequence Number: 2195774
• Product Code: NCX
• UDI-Device Identifier: 00849111075091
• UDI-Public: 00849111075091
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2019

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-3893
• Device Catalogue Number: 8700-0657-01
• Device Lot Number: 95695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1