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

Model Number	IC-4593
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The solex catheter in complaint will not be returned for investigation because it was disposed by the customer.Since the catheter was not returned, an investigation could not be performed.Review of the device history record was not performed because the lot number is unknown.
Event or Problem Description
As reported, a (b)(6) pounds (b)(6) years old male was hospitalized for post cardiac arrest.The patient had a smooth insertion of the solex 7 catheter (lot number unknown) through the left internal jugular.After 72 hours (3 days) of dwell time, at 4:45 am, the user's facility nurse was given order to give bolus of 1 liter normal saline to the patient and at 5:30 am, the nurse noticed purple swelling on the left side face of the patient.Therapy stopped immediately and solex 7 catheter was removed.Icy catheter was placed in the patient's left femoral vein to continue with therapy.Icy catheter had been used for pressor and cooling for additional 3 days without any issue.Based on zoll medical safety assessment, the purple swelling on the left side face of the patient was related to use error, the facility nurse did not insert the solex 7 catheter far enough.Zoll has recommended for customer re-training.

• Brand Name: ZOLL IVTM SOLEX 7 HEPARIN CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 7830546
• Report Number: 3010617000-2018-00874
• Device Sequence Number: 16596353
• Product Code: NCX
• UDI-Device Identifier: 00849111075503
• UDI-Public: 00849111075503
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/29/2018

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 08/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 78