MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL IVTM THERMOGARD XP; THERMAL REGULATING SYSTEM

Model Number 8700-0650-XX

Device Problems Insufficient Cooling (1130); Device Issue (2379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

The product was returned to zoll on 06/13/2018 for investigation; however, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Event Description

As reported, the guidewire with unknown lot number was a bit difficult to push back after insertion of quattro cath (ln 68874) on the patient's femoral right side.The dwell time of the catheter was 14 hours.Therapy started successfully but after few hours later, the thermogard xp ivtm system with unknown serial number target temperature could not reached fast and precise.Patient's target temperature was 33°c however, the patient temperature stayed at 36°c.X-ray results showed that there was a little kink of the catheter, and also, the red wheel (flowindicator) at the suk with unknown lot number was not moving.Additionally, the role-pump gas moved.No leaked fluid observed.There were no system alarms noticed during therapy.Experienced practitioners has decided to removed the catheter about 14 hours into the patient therapy and was cooled with conventional methods, e.G.Coolpacks and saline.Resuscitation was the primary cause for the patient hospitalization.No intervention needed or planned due to the event.No known impact or patient consequence was reported.

• Brand Name: ZOLL IVTM THERMOGARD XP
• Type of Device: THERMAL REGULATING SYSTEM
• 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: kimthoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7661547
• MDR Text Key: 113191972
• Report Number: 3010617000-2018-00687
• Device Sequence Number: 1
• Product Code: NCX
• UDI-Device Identifier: 00849111075022
• UDI-Public: 00849111075022
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K072234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8700-0650-XX
• Device Catalogue Number: 8700-0650-XX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1