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

Model Number	SL-2593CO
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The zoll catheter was returned to zoll on 11/14/2017 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.
Event or Problem Description
As reported, the solex catheter was observed to have a leak.According to the reporter, there was no alarms noted from the thermogard xp ivtm console.Approximately 6 hours into the patient therapy, the attending nurse noted that the 500 cc bag of saline was empty.The bag was replaced with a 1000 cc bag and about 4 hours later, the nurse noted the bag had lost 500 cc of saline.The health care team ultimately decided to discontinue the solex and place a femoral line using the quattro catheter.No further issues were noted.There were no patient consequence reported.
Additional Manufacturer Narrative
Evaluation of the returned catheter confirmed the customer reported issue as a shaft leak at the proximal infusion port.During manufacturing, all solex 7 catheters are 100% inspected for leaks by subjecting them to pressure testing.Thus, it is probable that the shaft leak was caused by abrasive surface contact to the catheter during device operation.All catheters go through a thorough 100% inspection and test prior to and during catheter assembly process to ensure visual, structural and functional integrity.This includes destructive testing to verify burst strength prior to lot release.Historical complaints were reviewed for information related to the reported complaint and there was no similar complaint reported for solex 7 catheters with lot number 71881.

• Brand Name: ZOLL IVTM SOLEX 7 CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 7077610
• Report Number: 3010617000-2017-01070
• Device Sequence Number: 16168480
• Product Code: NCX
• UDI-Device Identifier: 00849111075541
• UDI-Public: 00849111075541
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2018

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: SL-2593CO
• Device Catalogue Number: 8700-0793-14
• Device Lot Number: 71881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/09/2017
• Supplement Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 12/01/2017
• Supplement Report FDA Received Date: 01/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 109