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	Inflammation (1932)
Date of Event	03/08/2022
Type of Reportable Event	Serious Injury
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.It is unknown if any amount of one bad of sterile cold saline was entered the patient's vasculature, or entered subcutaneous area on the patient's thigh, or all saline was on the linen.Even if saline entered the patient's vasculature, administration of saline i.V.Up to 1.5 l is one of the common methods of treatment at the hospitals and should not harm a patient.The customer will benefit from additional training on how to handle suspected catheter leak.The fluid ran into the patient's vasculature is an anticipated event.Based on available information, no patient's effect was observed.Catheter leak is probably related to device and to procedure.
Event or Problem Description
During ivtm therapy, customer noticed the thermogard ivtm system (sn unknown) had alarmed and the saline bag was nearly empty and that the linen was wet.Customer suspected a icy catheter (lot #unknown) balloon leak.The catheter was flushed without resistance and no blood was noted.They removed the catheter and placed a solex 7 and continued therapy.Prior to when issue noticed, the patient had reached the target temperature and the thermogard console maintained its target temperature setting.Per reporter, the patient's thigh was a little swollen.Please see the following related mfr report: mfr 3010617000-2022-00423 for the thermogard ivtm system (sn unknown).
Event or Problem Description
During ivtm therapy, customer noticed the thermogard ivtm system (sn unknown) had alarmed and the saline bag was nearly empty and that the linen was wet.Customer suspected a icy catheter (lot #168993) balloon leak.The catheter was flushed without resistance and no blood was noted.They removed the catheter and placed a solex 7 and continued therapy.Per reporter, the patient's thigh was a little swollen.
Additional Manufacturer Narrative
Additional information b5 and d4: icy catheter lot number added.The reported complaint of "the icy catheter (lot #168993) leak" was confirmed during functional testing of the returned catheter.A liquid emission/leak was observed from the in luer during the lumen crosstalk test.The probable root cause is a weakened wall between the lumens, which withstood pressure testing during manufacturing but resulted in a leak during clinical use.Visual inspection of the returned catheter was performed, and dried blood residue was observed on the balloons and the luered tubings.No physical damage was observed.During functional testing, all infusion ports and extension tubes were flushed without resistance.The returned catheter was connected to the pressurized inflation device for one minute, and the balloons were fully inflated when pressurized up to 100 psi.Upon pressurizing the catheter, no leak was observed from the catheter balloons.However, water emission/leak was observed from in luer during the lumen crosstalk test.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 was no previous history of complaint reported for icy catheter with lot #168993.
Additional Manufacturer Narrative
Correction h10, the relationship to device and procedure on the msa has been revised.Catheter leak is causal related to device and to procedure.

• 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: 14057537
• Report Number: 3010617000-2022-00322
• Device Sequence Number: 14695848
• Product Code: NCX
• UDI-Device Identifier: 00849111075190
• UDI-Public: 00849111075190
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IC-3893
• Device Catalogue Number: 8700-0782-01
• Device Lot Number: 168993
• 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: 03/09/2022
• Supplement Date Received by Manufacturer: 06/13/2022; 09/07/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 07/08/2022; 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown