MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL IVTM SOLEX 3 LUMEN CATHETER; CENTRAL VENOUS CATHETER

Model Number	SL-2593
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the zoll console in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
It was reported that (b)(6) male patient (weighing (b)(6)) was hospitalized post head injury.A solex-7 catheter was inserted smoothly in left subclavian vessel by a physician.The temperature set point on the console was 37°c.The patient temperature at the start of the ivtm system was 37.8°c and the desired target temperature was 37°c.Approximately 12-24 hours after therapy was initiated, it was noted that the patient gown was wet and patient temperature spiked.The rn noted that the catheter leaked around insertion site and saline bag did not run dry.The nurse was unable to visualize insertion depth due to catheter dressing.Line undressed by resident only when new catheter was being rewired.The rn also stated that the catheter might not have been sutured down to the patient properly.The catheter was exchanged for a new solex-7 catheter.Therapy resumed with no further issue.There is no health injury to the patient.
Additional Manufacturer Narrative
The customer reported complaint of a solex catheter leak around insertion site was not confirmed.Evaluation of the returned device revealed no issues with the catheter.The catheter functioned as intended.During functional testing, the returned catheter was connected to a pressurized inflation device, and pressure was increased up to 100psi.No leaks were observed.No issues found during catheter deflation.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 was seen which may have contributed to the symptoms reported by customer at the insertion site.The medial and proximal ports are intended for infusion during therapy.If either lumen is infused during catheter indwelling, there is a likelihood of fluid observed at the insertions site.During manufacturing, all solex catheters are 100% inspected for leaks (pressure testing per (b)(4)).Only units that pass the testing are moved to the next process.

• Brand Name: ZOLL IVTM SOLEX 3 LUMEN CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 6200389
• Report Number: 3010617000-2016-00924
• Device Sequence Number: 323031
• Product Code: NCX
• UDI-Device Identifier: 00849111075152
• UDI-Public: 00849111075152
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K072234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2017

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-2593
• Device Catalogue Number: 8700-0671-01
• Device Lot Number: 64292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/22/2016
• Supplement Report FDA Received Date: 01/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 31 YR
• Patient Weight: 78