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

Model Number	8700-0660
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the zoll catheter 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 during patient use of the coolgard ivtm system and quattro catheter a possible catheter leak was observed.A female patient, (b)(6), was hospitalized for cardiac arrest.Her clinical symptoms were problems with maintaining body temperature, prior to cardiac arrest, therefore they had placed a bair hugger device over her.She had acute liver disease, continuous renal replacement therapy and coagulopathies (inr 3).The patient also had a medical history that included lupus and chronic kidney disease.The patient was to be treated for temperature management using the coolgard ivtm system.The quattro catheter was placed in her left femoral vein by an experienced physician.The insertion was smooth and only one attempt was made.The room temperature was 30 degrees celsius.The ivtm was set to max rate of cooling/warming.The set temperature point was 37 degrees celsius.The patient's temperature before starting the treatment was 35 degrees celsius and the desired temperature was 37 degrees celsius.A separate catheter (vas cath - venous catheter used for dialysis) was in use, line, which was placed in the lij (left internal jugular vein.The nurse on duty entered the patient's room to assess the patient and the ivtm console and found the saline bag to have less saline then it should (exact amount was not provided).The nurse performed a check of the suk and catheter by flushing the catheter with saline.There was no saline returned from the "out" port of the catheter and upon attempting to aspirate, blood was seen in the connected syringe, indicating that the saline was inside the patient and the catheter had a leak.The console displayed a visual airtrap alarm, however no audible alarm.The nurse put the system in standby.Dwell time of the catheter when this event occurred was 2 days.The temperature probe used was in the bladder (manufacturer bard).During this event the patient was also being treated for temperature management by utilization of the bair hugger.They discontinued use of this ivtm catheter for temperature management therapy, however they kept it in the patient's body to be used solely as a central line access for the next two days.No information was provided on any other temperature management therapy, other than bair hugger, used in place of the ivtm system.At the time of this event, the patient had a temporary vascath placed.The nurse reported that this event did not affect the treatment or outcome of the patient.No patient sequelae was reported.No additional information was provided.Note: the infusion of a 500 ml bag of saline into a patient would not present a serious injury to a person with functioning fluid balance physiology.The response would be the loss of the fluid via increased urine output.

• Brand Name: ZOLL IVTM QUATTRO CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 5658198
• Report Number: 3010617000-2016-00333
• Device Sequence Number: 308680
• Product Code: NCX
• UDI-Device Identifier: 00849111050050
• UDI-Public: 00849111050050
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 05/16/2016

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: 8700-0660
• Device Catalogue Number: 8700-0660-03
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2016
• Initial Report FDA Received Date: 05/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 75