MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL IVTM SUK DISPOSABLE; THERMAL REGULATING SYSTEM

Model Number	8700-0666
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The zoll console in complaint will not be returned for investigation.Therefore, a physical investigation will not be performed.A supplemental report will be filed if the product is returned and investigation has been completed.The reported leak was found after 30 minutes of treatment.It was caused by a faulty seal at the joint of the air trap.Therapy was interrupted long enough to exchange the suk.It was reported that there was sterile saline water leaked in the air trap system.Thirty minutes of sterile saline would not contribute to the cause of the patient's death.
Event or Problem Description
It was reported that during patient treatment the hospital staff observed a water leak in the ivtm thermogard xp air trap system.The leak appeared to be initiated at the join of the air trap cylinder and the lid.The water flooded the thermogard xp.Patient therapy was interrupted.The patient was a (b)(6) male, weighing (b)(6) who was hospitalized for post cardiac arrest.The reason for therapeutic ivtm was for therapeutic hypothermia.There were no adjunctive temperature management or relative procedures performed on the patient.A zoll catheter was successfully placed into the right femoral vein.Catheter insertion was made in one attempt.The insertion was smooth by an experienced physician.The console was set to max mode.The patient temperature at the start of therapy was 34.9 degrees celsius.The target temperature set point on the console was 33.0 degrees celsius.The reported issue was observed, 30 minutes into therapy when the patient's temperature was 33.1 degrees celsius.The warming rate for therapy had not started.The dwell time the catheter was kept in the patient was approximately 26 hours.The suk was replaced, treatment was competed.There were no system alarms noticed during treatment.It was reported that the patient expired.The cause of death was not provided, however it was stated that the death was not related to the zoll thermogard xp.

• Brand Name: ZOLL IVTM SUK DISPOSABLE
• Common Device Name: THERMAL REGULATING SYSTEM
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 5465270
• Report Number: 3010617000-2016-00115
• Device Sequence Number: 302293
• Product Code: NCX
• UDI-Device Identifier: 00849111075329
• UDI-Public: 00849111075329
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K014241
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/26/2016

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: No Information
• Device Model Number: 8700-0666
• Device Catalogue Number: 8700-0666-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2016
• Initial Report FDA Received Date: 02/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 85