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

Model Number	8700-0671
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The solex catheter (s/n (b)(4)) was returned to zoll san jose for evaluation.Dhr review for solex catheter bonding lot no.51129 found no nonconformities.A visual inspection found no visual discrepancies or issues.All lumens flushed as intended, and specifically, no issues with the medial and proximal infusion ports.No leaks were noticed during flushing.No cracks were observed.No abnormalities with the catheter were seen which may have contributed to the symptom seen at the insertion site.Functional testing was performed, no leaks were observed.In summary, the reported complaint of catheter leak was not confirmed.Evaluation of the returned device revealed no issues with the catheter.The catheter functioned as intended.The medial and proximal ports are intended for infusion during therapy.If either lumen is infused during catheter in dwelling, there is a likelihood of fluid observed at the insertion site.It is likely that no liquid was observed when the distal port was flushed, because the distal infusion outlet is located further from the insertion site than the medial and proximal infusion outlets.During manufacturing, all solex catheters are 100% inspected for leaks (pressure testing per mpi02-052).Only units that passed are moved to the next process.
Event or Problem Description
It was reported that during patient treatment with an ivtm solex catheter a leak near the catheter insertion area was observed.A (b)(6) female patient weighing (b)(6) was hospitalized for cerebral abscess versus intracerebral empyema.The reason for therapeutic ivtm was fever management.A zoll solex catheter was inserted in the right jugular vein by a physician who had never placed a solex catheter.Catheter insertion was smooth.On day 3, the nurse checking on the patient found that the back of the patient's neck was wet.After further investigation, the leaking seemed to be coming from the insertion site of the catheter.She called the physician who inspected the catheter site, re-dressed the catheter site, and had the nurse move the 3% normal saline drip from proximal to the distal port of the catheter.Per the nurse, all 3 ports of the triple lumen were still drawing back blood without any issues.When flushing distal port, no leaking was noted around insertion site.However, when flushing the medial and proximal ports, leaking was noted around insertion site.Nurse also stated that the fluid leaking was clear and cold.No alarms were heard from the machine, including the air trap alarm.There was no air noted in the air trap.The physician was concerned that the catheter was cracked.The physician stated that the insertion site was red and was hard upon palpation.The patient was complaining about pain around the site.The catheter was removed since the physician did not feel comfortable about leaving it in.Fever management was still required for this patient, a separate standard central line was placed after solex removal for iv access.The right inferior jugular vein was dressed and there was no longer leaking observed from the site.No patient sequelae was reported.No additional information was provided.

• Brand Name: ZOLL IVTM SOLEX CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 5589426
• Report Number: 3010617000-2016-00277
• Device Sequence Number: 16239338
• Product Code: NCX
• UDI-Device Identifier: 00849111075152
• UDI-Public: 00849111075152
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/19/2016

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: 8700-0671
• Device Catalogue Number: 8700-0671-01
• Device Lot Number: 51129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2016
• Initial Report FDA Received Date: 04/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 76