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

Model Number	8700-0781-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned cool line catheter confirmed the customer reported complaint.During functional testing, the catheter was connected to a pressurized inflation device.Capping the "out" luer and connecting the "in" luer to the pressure inflation device, immediately upon pressuring the catheter, a pinhole leak was noted at the proximal end of the proximal balloon.During manufacturing all cool line catheters are 100% inspected for leaks by subjecting them to pressure testing.Only units that passed are moved to the next process.Probable causes for the reported complaint could be a latent material defect.Historical complaints were reviewed for service information related to the reported complaint and there was one similar complaint for cool line catheter leak with lot # 66447 under ccr # (b)(4) reported on (b)(6) 2017.The reported leak was confirmed during evaluation a patient with sustained a total body surface area (tbsa) burn trauma with low temperature was inserted a cool line catheter for ivtm treatment.Intended duration of cooling time was several days, as long as needed for normothermia for this burn patient with low body temp.Target temp was set up as 37.5.Catheter insertion was smooth, no issues were noted.Physician who actually placed the line, stated that cool line was j-wired after a first line (regular cvc) had been placed and removed.Catheter was placed l side.Patient was cooled for 2 days.The target patient temperature was achieved and had been maintained between 36.5 to 37.3 celsius.Day two after the initiation of cooling, the interruption occurred.At an unspecified time during treatment, the hospital nurse observed that the fluid level in the saline bag was running low.No signs of physical leak on the floor or on the patient's bedside was observed, however the first 500 cc saline bag emptied and the nurse changed the bag out.Nurse noted one alarm but did not remember the error notification.A catheter leak was suspected, the cool line catheter was removed, and the ivtm treatment was discontinued.No known impact or patient consequence was reported.A third line was j-wired but it was a regular cvc (not another ivtm catheter, but just a regular cvc).Patient expired a few days later.The cause of the outcome was attributed to multiple trauma.In agreement with a customer, the patient's death was related to a clinical condition of total body surface area burn trauma and not related to ivtm device or procedure.
Event or Problem Description
A patient who sustained a total body surface area (tbsa) burn trauma was inserted a cool line catheter for ivtm treatment.On day 2 of ivtm treatment, the hospital nurse reportedly observed that the fluid level in the saline bag emptied.It was noted that during this time, the target patient temperature was achieved and had been maintained.Upon inspection, no physical signs of leak on the patient's bedside or on the floor was reported.No alarm was observed on the console.A catheter leak was suspected, and the cool line catheter was removed.As target temperature had been achieved and maintained, the ivtm treatment was discontinued.Further information from the clinical specialist stated that the patient expired a few days after, the cause of the outcome was attributed to multiple trauma.No further information was provided.

• Brand Name: ZOLL IVTM COOL LINE CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 7149914
• Report Number: 3010617000-2017-01109
• Device Sequence Number: 1917727
• Product Code: NCX
• UDI-Device Identifier: 00849111075190
• UDI-Public: 00849111075190
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/27/2017

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: 8700-0781-01
• Device Catalogue Number: 8700-0781-01
• Device Lot Number: 66447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 12/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1