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

Model Number IC-4593

Device Problems Connection Problem (2900); Incomplete or Inadequate Connection (4037)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2021

Event Type  malfunction  

Manufacturer Narrative

The quattro catheter and start-up kit (suk) used at the time of the event will not be returned for evaluation, as they were discarded by the customer.Therefore, a physical investigation could not be performed and a root cause could not be determined.

Event Description

A patient was admitted for ivtm therapy, and the quattro catheter (lot # unknown) was inserted into the patient's left femoral vein.The patient's initial body temperature prior to the initiation of the ivtm therapy was not provided by the customer.When the user wanted to start the re-warming phase of the treatment, it was noted that the 500-ml saline bag was empty.The dwell time of the catheter was about 30 hours when the issue was noticed.Upon inspection, no fluid was observed on the floor or on the thermogard console.However, the patient's sheets were wet, and it was noted that the in/out luers on the start-up kit (suk) (lot # unknown) to the catheter were not properly connected.There was no blood tinge observed in the tubing.As reported, the therapy was paused for 8 hours.The patient's body temperature was 32.8°c, but the physician assessed the patient and concluded that there was no adverse impact on the patient as a result of the 8-hour delay in therapy.Subsequently, the suk and the 500-ml saline bag were replaced, and the therapy was continued and completed with the same quattro catheter and thermogard console.No device malfunction was reported on the thermogard console.No consequences or impact to the patient.

• Brand Name: ZOLL IVTM QUATTRO CATHETER
• Type of Device: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 11662506
• MDR Text Key: 247541802
• Report Number: 3010617000-2021-00326
• Device Sequence Number: 1
• Product Code: NCX
• UDI-Device Identifier: 00849111075282
• UDI-Public: 00849111075282
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IC-4593
• Device Catalogue Number: 8700-0783-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1