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

Model Number	CL-2295
Medical Device Problem Codes	Fluid/Blood Leak (1250); Difficult to Remove (1528); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the product for investigation.A follow-up report will be submitted when the product is returned and investigation has been completed.Administration of sterile saline i.V.Up to 1.5 l is one of the common methods of treatment at the hospitals and should not harm a patient.
Event or Problem Description
A (b)(6) y.O.Patient experienced intraparenchymal hemorrhage and was admitted.Ivtm therapy was used to prevent neurogenic fever.After 7 days of ivtm therapy, the thermogard ivtm system (serial #unknown) generated an air trap alarm.The hospital staff observed blood on the start-up kit (suk) and also noticed the 500ml normal saline (ns) bag was empty.Ivtm therapy was stopped and thermogard system was placed on standby.While the cool line catheter (lot#149663) was being pulled out, it got stuck half way.Computerized tomography (ct) scan was performed and negative for contraindications and catheter was successfully removed.Per reporter, the cool line catheter was intact and balloons were separated, but connected to the catheter when removed, no sign of missing balloon pieces.No consequences or impact to patient.Please see the following related mfr report: mfr # 3010617000-2021-00282 for the thermogard ivtm system (sn unknown).

• 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: 11468217
• Report Number: 3010617000-2021-00187
• Device Sequence Number: 11668805
• Product Code: NCX
• UDI-Device Identifier: 00849111075190
• UDI-Public: 00849111075190
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2021

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: CL-2295
• Device Catalogue Number: 8700-0781-01
• Device Lot Number: 149549
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 127