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

Model Number	IC-3893AE
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported complaint of the icy catheter (lot #155014) leak was confirmed during functional testing.A bonding leak was observed at the proximal end of the medial balloon.The probable root cause for the reported complaint could be due to a latent defect at the bond.A visual examination of the returned catheter was performed and found no physical damage to the catheter.Dried blood residue was observed in the balloons.Functional testing of the returned catheter was performed.All infusion ports and extension tubes were flushed without resistance.The catheter was connected to a pressurized inflation device, the balloons were fully inflated when pressurized up to 100 psi.Immediately upon pressurizing the catheter, a bonding leak was observed at the proximal end of the medial balloon.Thus, confirming customer 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 a catheter with lot number 155014.Administration of sterile cold 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 should be re-trained on usage of the catheter to assure appropriate location of the catheter during cooling therapy.
Event or Problem Description
During the ivtm therapy, customer noticed that the 500ml normal saline bag got emptied and no traces of saline fluid was observed on the console, on the patient bed, or on the floor.The thermogard ivtm system generated an "airtrap" alarm.Per reporter, the airtrap alarm was cleared and thermogard system is functioning properly.The customer suspects a leak from the icy catheter (lot #155014).The catheter insertion was smooth and dwell time was 2 days.The physician decided to discontinue the ivtm therapy because the patient was in good condition and the ivtm therapy was no longer required.No consequences or impact to patient.

• 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: 11781081
• Report Number: 3010617000-2021-00359
• Device Sequence Number: 3659295
• Product Code: NCX
• UDI-Device Identifier: 00849111075336
• UDI-Public: 00849111075336
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2021

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-3893AE
• Device Catalogue Number: 8700-0782-40
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR