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	Death (1802)
Date of Event	10/24/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
The reported complaint of "the icy catheter (lot #93192) leak" was confirmed during the functional testing of the returned catheter.Bonding leak was observed at the proximal end of the medial balloon.The probable root cause for the reported complaint was due to a latent defect at the bond.Upon visual inspection, no physical damage was observed.Noticed dried blood residue on the catheter balloons and on the proximal luer tubing.During functional testing, all infusion ports and extension tubes were flushed without resistance.The catheter was connected to a pressurized inflation device.Immediately upon pressurizing the catheter, a bond leak was observed at the proximal end 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 service information related to the reported complaint and there was no previous history of complaint reported for suk with lot number 93192.Based on zoll medical safety assessment, the event of death was serious because it met criteria for seriousness (death).The patient was in a critical condition after cardiac arrest.Infusion of 1l of sterile saline is common in the management of critically ill patients and likely not contributed in the event of the patient's death.Death was probably due to the patient's clinical condition.
Event or Problem Description
After less than 24 hours of ivtm therapy, customer reported that the 500ml bag of saline had emptied.There was no fluid observed on the patient's bed, floor or the console.Second saline bag was placed and also drained.The icy catheter (lot #93192) was removed and shows compromised balloon.There was no report of the thermogard ivtm system had alarmed.The saline fluid was clearly infused into the patient.Patient death was reported.However, cause of death is unknown.

• 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: 9359195
• Report Number: 3010617000-2019-01042
• Device Sequence Number: 11233596
• Product Code: NCX
• UDI-Device Identifier: 00849111075220
• UDI-Public: 00849111075220
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (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): 11/21/2019

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-3893AE
• Device Catalogue Number: 8700-0782-40
• Device Lot Number: 93192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death