MAUDE Adverse Event Report: ZOLL CIRCULATION INC. SUK CUSTOM LUER; THERMAL REGULATING SYSTEM

Model Number	CG-500D
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/19/2022
Type of Reportable Event	Death
Event or Problem Description
During ivtm therapy on a 59 year old male post cardiac arrest patient, the customer reported there was a leak observed from the air trap of the start-up kit (suk) (lot #unknown).The thermogard xp ivtm system displayed an air trap alarm.The suk was replaced and the alarm was cleared.The therapy was continued on the same console without issue.The dwell time was 32 hours.Per the customer, the patient died, and the outcome was not related to the ivtm console.
Additional Manufacturer Narrative
Zoll has received the start-up kit for investigation.A follow-up report will be submitted when the product investigation has been completed.Only limited information is available, and it seems that the patient died due to sickness, and the customer said that the patient's death was not related to the zoll catheter.Event of death was serious because it met criteria for seriousness (death).Usually critically ill patients receive ivtm therapy and mortality rate is high.Probably outcome death related to the patient's clinical condition and not to ivtm therapy.Death was not related to zoll device and procedure.
Additional Manufacturer Narrative
B5 (describe event or problem)and d4 (additional device information) were corrected.The customer reported a complaint of a leak at the air trap of the start-up kit (suk) (lot #173284) was confirmed during visual inspection.As received, the air trap's top cap was detached from the polycarbonate tubing.The probable root cause could be a latent defect at the bond.Visual inspection of the returned suk was performed and found the air trap's top cap was coming loose/detached from the polycarbonate tubing, thus confirming the reported complaint.No other physical damage was observed.Due to the condition in which the suk was received, the functional leak test could not be performed.Historical complaints were reviewed for information related to the reported complaint, and there was no previous history of complaints reported for the suk with lot # 173284.
Event or Problem Description
During ivtm therapy on a 59 year old male post cardiac arrest patient, the customer reported there was a leak observed from the air trap of the start-up kit (suk) (lot #173284).The thermogard xp ivtm system displayed an air trap alarm.The suk was replaced and the alarm was cleared.The therapy was continued on the same console without issue.The dwell time was 32 hours.Per the customer, the patient died, and the outcome was not related to the ivtm console.
Additional Manufacturer Narrative
Following the medical safety assessment, zoll concluded that the death was not related to the start-up kit or ivtm therapy, but rather to the patient's clinical condition.Therefore, submitting this supplemental mdr to retract the initial and supplemental #1 mdr submission.

• Brand Name: SUK CUSTOM LUER
• Common Device Name: THERMAL REGULATING SYSTEM
• Manufacturer (Section D): ZOLL CIRCULATION INC.; 2000 ringwood ave; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 14691197
• Report Number: 3010617000-2022-00649
• Device Sequence Number: 5176513
• Product Code: NCX
• UDI-Device Identifier: 00849111075336
• UDI-Public: 00849111075336
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K150046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2024

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: CG-500D
• Device Catalogue Number: 8700-0784-01
• Device Lot Number: 173284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2022
• Supplement Date Received by Manufacturer: 07/01/2022; 08/19/2024
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 07/15/2022; 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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: Death
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 87 KG