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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The start-up kit (suk) (lot #172206) was connected to the thermogard xp ivtm system, and priming was performed to initiate the ivtm therapy for a (b)(6)-year-old female patient (weight - (b)(6) lbs.).An icy catheter (lot #unknown) was used for the ivtm therapy.After an unknown period, the thermogard xp ivtm system (sn unknown) generated an air trap alarm, and many air bubbles were noted in the suk air trap.The user observed an empty saline bag and blood tinge on the suk tubing, indicating a potential catheter leak.The customer discarded the catheter and the suk.No consequences or impact to the patient.The customer provided no further information.For the above-reported event, zoll received medwatch report # (b)(4) on (b)(6) 2022.Please see the following related mfr report: mfr 3010617000-2022-00241 for the thermogard xp ivtm system.
Additional Manufacturer Narrative
The catheter involved in the reported complaint will not be returned for investigation because the customer has disposed of it.Therefore, a physical investigation could not be performed, and the root cause could not be determined.
Additional Manufacturer Narrative
The catheter involved in the reported complaint will not be returned for investigation because the customer has disposed of it.Therefore, a physical investigation could not be performed, and the root cause could not be determined.
Event or Problem Description
The start-up kit (suk) (lot #172206) was connected to the thermogard xp ivtm system, and priming was performed to initiate the ivtm therapy for a (b)(6)-year-old female patient (weight - (b)(6)).An icy catheter (lot #unknown) was used for the ivtm therapy.After an unknown period, the thermogard xp ivtm system (sn unknown) generated an air trap alarm, and many air bubbles were noted in the suk air trap.The user observed an empty saline bag and blood tinge on the suk tubing, indicating a potential catheter leak.The customer discarded the catheter and the suk.No consequences or impact to the patient.The customer provided no further information.For the above-reported event, zoll received medwatch report # (b)(4) on (b)(6) 2022.Please see the following related mfr report: mfr 3010617000-2022-00241 for the thermogard xp ivtm system.

• 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: 13609184
• Report Number: 3010617000-2022-00192
• Device Sequence Number: 20292051
• Product Code: NCX
• UDI-Device Identifier: 00849111075237
• UDI-Public: 00849111075237
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2022

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-3893
• Device Catalogue Number: 8700-0782-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 02/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 55 YR
• Patient Sex: Female
• Patient Weight: 106 KG
• Patient Race: Black Or African American