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

Model Number	8700-0654
Medical Device Problem Codes	Leak/Splash (1354); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/10/2016
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
It was reported that after 3 days of ivtm treatment a leak was observed.The patient was hospitalized for a sah (subarachnoid hemorrhage).The patient was treated with the ivtm thermogard for post-surgery fever management.It was reported that the patient's body temperature was well controlled.On the third day after the treatment began, it was observed that the saline level was low.It was determined that approximately 50-100 ml of saline leaked into the patient.No error message or alarm was noticed.When the saline infusion bag was replaced, blood was observed in the cool line catheter and suk (star-up-kit).The use of thermogard was terminated and the catheter was removed.The catheter was inspected by the user and they stated that no sign of a leak was observed.Fever management was maintained by the administration of antipyretics (nsaids).The patient's condition is stable.
Additional Manufacturer Narrative
A cool line catheter (lot # 55520) was returned to zoll san jose for evaluation.Device history record (dhr) was reviewed and no previous related complaints were reported for this cool line catheter (lot # 55520).A visual inspection for the returned unit revealed traces of desiccated blood in the balloons, shaft, luered tubings and infusion ports.All luered tubings and infusion ports flushed without issues.No other discrepancies were observed.When the catheter was connected to a pressurized inflation device, a pinhole leak was noted at the distal balloon.Following the test, all balloons deflated successfully without any issues.The evaluation of the returned cool line catheter confirmed the customer reported issue.A pinhole leak was found at the distal balloon of the catheter which was replicated by the functional leak test performed.During manufacturing, all cool line catheters are 100% inspected for leaks.

• 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: 5565136
• Report Number: 3010617000-2016-00242
• Device Sequence Number: 16239324
• Product Code: NCX
• UDI-Device Identifier: 00849111075046
• UDI-Public: 00849111075046
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2016

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: Health Professional
• Device Model Number: 8700-0654
• Device Catalogue Number: 8700-0654-01
• Device Lot Number: 55520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2016
• Supplement Report FDA Received Date: 04/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1