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

Model Number	CL-2295AE
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of "the cool line catheter (lot # 147000) leak" was confirmed during the functional testing of the returned catheter.A pinhole leak was observed from the middle of the distal balloon during the pressure leak test.The probable root cause for the pinhole leak is due to a latent material defect.Upon visual inspection, no physical damage to the catheter was observed.Noticed suture thread on the manifold.Also, observed dried blood residue on the distal balloon.During functional testing, all infusion ports and extension tubes were flushed without resistance.The catheter was connected to the pressurized inflation device and immediately upon pressurizing the catheter, a pinhole leak was observed from the middle of the distal balloon.During manufacturing all catheters are 100% inspected for leaks by subjecting them to pressure testing.Only units that passed are moved to the next process.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for a catheter with a lot number 147000.Administration of sterile cold saline i.V.Up to 1.5 l is one of the common methods of treatment at the hospitals.In agreement with a customer, there was no patient's effect attributed to zoll catheter.
Event or Problem Description
During the 3rd day of the ivtm therapy, the user observed 500 ml of empty saline bag.Following this, another 500 ml saline bag was replaced and after an unspecified period of time, the user noticed an almost empty saline bag.No leak was observed on the floor, around the console or on the bed and no blood tinge was noticed on the suk tubing.Suspecting cool line catheter leak and approximately 750 ml of saline infusion.The dwell time of the catheter was approximately 60 hours.The catheter was replaced and ivtm therapy continued.No consequences or impact to patient.

• 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: 10538781
• Report Number: 3010617000-2020-00882
• Device Sequence Number: 14337173
• Product Code: NCX
• UDI-Device Identifier: 00849111075213
• UDI-Public: 00849111075213
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2020

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-2295AE
• Device Catalogue Number: 8700-0781-40
• Device Lot Number: 147000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 09/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 100