MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL IVTM COOL LINE CATHETER; CENTRAL VENOUS CATHETER

Model Number	8700-0654-01
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the zoll catheter in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
A (b)(6) male patient, weiging (b)(6) was hospitalized for post cardiac arrest.The reason for therapeutic ivtm was for hypothermia.The patient temperature at the start of therapy was 36.3° celsius.The thermogard console was set to max mode and the temperature was set at 33° celsius.An esophageal and rectal temperature probes were used to measure patient temperature.A zoll cool line catheter was successfully placed into the right subclavian vein by an experienced physician.The insertion was reportedly smooth.After 2 hours, the airtrap alarmed on the console.The hospital staff observed blood backing up into the zoll start-up kit (suk) line.No leaks or breaks were observed in the suk tubing.After the leak was discovered, the catheter was disconnected and it appeared there was only approximately 100-150ml of saline left in the bag.Another zoll cool line catheter was immediately placed and the patient was able to successfully continue with the therapy.No adverse patient sequelae reported to the patient.Later the staff hooked up a 10 cc saline syringe to the catheter and a fine stream of saline was observed coming from the proximal end of the distal balloon on the catheter.
Additional Manufacturer Narrative
A cool line catheter was returned to zoll (b)(4) for evaluation.No evaluation was performed on the device based on the condition it was returned(mold developed inside the catheter bag).Device history record was not reviewed as lot number was not available.As the evaluation was not performed on returned device, reported complaint cannot be determined.There was no patient injury or death attributable to this complaint.No additional action required due to this low frequency complaint.

• Brand Name: ZOLL IVTM COOL LINE CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 5530756
• Report Number: 3010617000-2016-00209
• Device Sequence Number: 625258
• Product Code: NCX
• UDI-Device Identifier: 00849111075046
• UDI-Public: 00849111075046
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2016

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: 8700-0654-01
• Device Catalogue Number: 8700-0654-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2016
• Supplement Report FDA Received Date: 05/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 103