MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL IVTM SOLEX 7 CATHETER; CENTRAL VENOUS CATHETER

Model Number	IC-4593
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The solex 7 catheter and suk will not be returned to zoll for investigation since this was a covid-19 patient.The catheter and suk were dispose by the customer.
Event or Problem Description
During ivtm therapy, nurse reported that the patient's temperature was rising and that the pin wheel on the start-up kit (suk) was not spinning.A zoll clinical representative provided troubleshooting guidelines over the phone with no success.Zoll clinical representative then went to the facility and disconnected the suk from the patient and connected it to itself and pressed the run button, pin wheel started to spin.All three central line ports flushed with saline and was able to draw back blood with no problems.Also, the balloon luers were flushed with 2ml of saline and felt a slight resistance.The suk was reconnected back to the patient but pinwheel did not spin.Saline fluid slowly moving through the tubing.The insertion of the solex catheter was smooth by a experience physician.The tubing going into the "in" luer was cool to the touch, but the "out" luer was warm.The balloon was difficult to see on the x-ray.The physician exchanged the solex 7 catheter with a regular central line to continue with ivtm therapy.The nurse stated that there was no problems with catheter removal and dwell time was 24 hours.No consequences or impact to patient.

• Brand Name: ZOLL IVTM SOLEX 7 CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• MDR Report Key: 10003015
• Report Number: 3010617000-2020-00411
• Device Sequence Number: 16886182
• Product Code: NCX
• UDI-Device Identifier: 00849111075503
• UDI-Public: 00849111075503
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/27/2020

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: IC-4593
• Device Catalogue Number: 8700-0793-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 04/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 136