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

Model Number	IC-4593
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During the rewarming phase of ivtm therapy, customer reported that a 1000ml saline bag was replaced because it emptied, and a 500ml saline bag had started to empty.When the customer noticed the 1000ml bag emptied, and no saline was found on the thermogard ivtm system, patient's bed or on the floor.The customer replaced the 1000ml saline bag with a 500ml saline bag, and the thermogard ivtm system and the start-up kit (suk) to continue with rewarming treatment.Later, the customer noticed the 500ml bag started to empty and check for fluid leak.No saline was found on the thermogard ivtm system, patient's bed or on the floor, and no blood-tinge was observed in the catheter, assumed to be infused into patient.The customer called a zoll educator, and customer was advised that there's appeared to be a leak in the balloon of the quattro catheter (lot # unknown) and stop treatment.The customer placed a new catheter to continue with treatment.Per reporter, the first thermogard ivtm system was functioning properly with no alarms or error messages, it was changed as an effort to ensure there were no unidentified console issues.Based on nurse recollection, approx.1200ml infused in the patient.Patient's status information was requested but the customer did not provide a response.
Additional Manufacturer Narrative
Zoll has received the catheter however, the investigation is still in progress.A follow-up report will be submitted when the investigation has been completed.1500 ml saline infusion over many minutes is tolerated most patients.Not injury reported.The event of saline infusion is probably related to the device and to the procedure.
Additional Manufacturer Narrative
Updated section b5 and h6 per additional information received on the patient status.The customer reported a complaint that "there's appeared to be a leak in the balloon of the icy catheter (lot #188022)" was confirmed during the functional testing.During the functional pressure leak test, a bonding leak was observed at the proximal end of the medial balloon.The probable root cause could be a latent defect in the bond.A visual inspection of the returned catheter was performed and found no physical damage to the catheter.Blood residue was observed in the balloons.A functional leak test of the returned catheter was performed.All infusion ports and lumens were flushed without resistance.The catheter was connected to a pressurized inflation device during the functional pressure leak test.Upon pressurizing the catheter up to 100 psi, a bonding leak was observed at the proximal end of the medial balloon, thus, confirming the reported complaint.It is unlikely that the defective catheter was shipped.All catheters are 100% inspected for leaks during manufacturing 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 no previous history of complaint was reported for the icy catheter with lot #188022.Administration of sterile cold sterile cold saline iv up to 1.5 l is one the common methods of treatment at the hospitals and should not harm a patient.The reported of approx.1200ml infused in the patient is causal related to the device and procedure.
Event or Problem Description
During the rewarming phase of ivtm therapy, customer reported that a 1000ml saline bag was replaced because it emptied, and a 500ml saline bag had started to empty.When the customer noticed the 1000ml bag emptied, and no saline was found on the thermogard ivtm system, patient's bed or on the floor.The customer replaced the 1000ml saline bag with a 500ml saline bag, and the thermogard ivtm system and the start-up kit (suk) to continue with rewarming treatment.Later, the customer noticed the 500ml bag started to empty and check for fluid leak.No saline was found on the thermogard ivtm system, patient's bed or on the floor, and no blood-tinge was observed in the catheter, assumed to be infused into patient.The customer called a zoll educator, and customer was advised that there's appeared to be a leak in the balloon of the icy catheter (lot #188022) and stop treatment.The customer placed a new catheter to continue with treatment.Per reporter, the first thermogard ivtm system was functioning properly with no alarms or error messages, it was changed as an effort to ensure there were no unidentified console issues.Based on nurse recollection, approx.1200ml infused in the patient, but there was no adverse impact to the patient.The patient recovered and discharged to a skilled nursing facility.

• Brand Name: ZOLL IVTM QUATTRO 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 nguyen ; 2000 ringwood ave; san jose, CA 95131
• MDR Report Key: 17537853
• Report Number: 3010617000-2023-00665
• Device Sequence Number: 6496637
• Product Code: NCX
• UDI-Device Identifier: 00849111075282
• UDI-Public: 00849111075282
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K072234
• 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): 08/25/2023

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-4593
• Device Catalogue Number: 8700-0783-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 08/13/2023
• Supplement Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2023
• 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