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

Model Number	IC-3893CO
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During ivtm therapy, the thermogard ivtm system (b)(4) generated an alarm and it displayed mid:01 post watchdog error message.The customer noted a nearly empty 1000 ml saline bag, blood-tinged in start-up kit (suk) tubing, and no leaked saline noted around the patient or on the floor around the thermogard system.An icy catheter lot #unknown balloon leak was suspected.It is unknown how much saline infused into the patient's body.Per the reporter, ivtm therapy continued without replacing the saline bag and catheter because the patient has completed the cooling phase and is now in the maintenance phase.Also, the intensivist did not want to remove the catheter due to the patient is fully anticoagulated and maybe at risk of bleeding.No other lines present at the insertion site.No further information was provided by the customer.Patient's status information was requested but the customer did not provide a response.Please see the following related mfr report: mfr 3010617000-2022-00499 for the thermogard console (b)(4).
Additional Manufacturer Narrative
Zoll has not received the product for investigation.A follow-up report will be submitted when the product is returned and investigation has been completed.
Additional Manufacturer Narrative
The reported complaint of a icy catheter (lot #161453) leak was confirmed during the functional testing.A bonding leak was observed at proximal end of medial balloon during the functional pressure leak test.The probable root cause of the reported leak was due to a latent defect at the bond.Visual examination of the returned icy catheter was performed, and no physical damage was found.Observed blood residues in the balloons and luered tubings.Functional testing of the returned catheter was performed, an all infusion ports and extension tubes were flushed without resistance.During the functional pressure leak test, the icy catheter was connected to a pressurized inflation device.Upon pressurizing the catheter up to 100 psi, a bonding leak was observed at proximal end of the medial balloon; thus, confirming the reported complaint.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 were 2 similar complaints reported for the icy catheter with lot number 161453.Ccr 59559, reported on september 6, 2021 and ccr 59587, reported on september 08, 2021.A balloon bond leak was noted due to a latent defect at the bond.
Event or Problem Description
During ivtm therapy, the thermogard ivtm system (sn (b)(6) generated an alarm and it displayed mid:01 (post watchdog) error message.The customer noted a nearly empty 1000 ml saline bag, blood-tinged in start-up kit (suk) lot #159800 tubing, and no leaked saline noted around the patient or on the floor around the thermogard system.An icy catheter (lot #161453) balloon leak was suspected.It is unknown how much saline infused into the patient's body.Per the reporter, ivtm therapy continued without replacing the saline bag and catheter because the patient has completed the cooling phase and is now in the maintenance phase.Also, the intensivist did not want to remove the catheter due to the patient is fully anticoagulated and maybe at risk of bleeding.No other lines present at the insertion site.No further information was provided by the customer.Patient's status information was requested but the customer did not provide a response.

• Brand Name: ZOLL IVTM ICY CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 14418149
• Report Number: 3010617000-2022-00497
• Device Sequence Number: 5451508
• Product Code: NCX
• UDI-Device Identifier: 00849111075527
• UDI-Public: 00849111075527
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2022

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-3893CO
• Device Catalogue Number: 8700-0782-14
• Device Lot Number: 161453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2022
• Supplement Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 05/17/2022
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown