MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL IVTM SOLEX 3 CATHETER; CENTRAL VENOUS CATHETER

Model Number	SL-2593
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The zoll solex catheter in complaint will not be returned for physical investigation.However, the customer did not report any malfunction or issues with the catheter or the temperature management procedure.It is not known at this time if the patient's bad condition after the first cardiac arrest was due to the complications related to cardiac arrest or the temperature management procedure.Survival rate in post-cardiac arrest patients is about 5-10%.Removal of the catheter probably did not contribute to the patient's death.Based on available information and internal medical safety assessment, the patient's death was related to the patient's critical clinical condition.
Event or Problem Description
A (b)(6) years old female patient was admitted after cardiac arrest and was placed on ivtm therapy for hypothermia in (b)(6) 2018.A solex catheter (ln unknown) was inserted into the patient's right internal jugular vein smoothly.Dwell time was 7 days.The patient was on deep vein thrombosis prophylaxis using heparin standard high dose.It was reported that the patient was in a bad condition.Ten minutes after removal of solex catheter, the patient went in cardiac arrest again and immediately was treated with cpr but unsuccessfully.Patient reported expired.The user not sure if second cardiac arrest was related to the removal of solex catheter but the doctor stated that the patient was in a bad condition during treatment.

• Brand Name: ZOLL IVTM SOLEX 3 CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 8005818
• Report Number: 3010617000-2018-01081
• Device Sequence Number: 1311917
• Product Code: NCX
• UDI-Device Identifier: 00849111075152
• UDI-Public: 00849111075152
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 10/25/2018

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: SL-2593
• Device Catalogue Number: 8700-0671-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR