MAUDE Adverse Event Report: COOK INC; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Event Description

Five patients were receiving continuous titrated infusion of calcium chloride (cacl) in the pediatric intensive care unit (picu).The patient's were receiving extracorporeal membrane oxygenation (ecmo) and/or continuous renal replacement therapies (crrt) through a femoral central venous catheter when the user facility experienced difficulty.It was reported that a few days into use of the central venous catheters the clinician noticed burns at the insertion sites in al five patients.It was discovered that there had been infiltration/extravasation of the cacl infusate.The infusion was discontinued.The wounds were treated.Certain cases required interventional procedures with a vascular surgeon and/or plastic surgeon.

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Manufacturer Narrative

Cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray.(b)(4).Event evaluation a review of the complaint history, manufacturing instructions (mi), quality control (qc), functional testing and a visual inspection of the complaint device was conducted for the purpose of this investigation.One device was returned in an open and used condition.Upon inspection, the tip of the catheter is coated in a white substance, most likely from the calcium chloride infusate.The distance between the sideports and catheter tip was measured to verify that it met specification.The catheter was clamped just above the side ports and injected with water to verify there were no leaks in the hub or shaft.No anomalies were found.Inspection indicates the returned device was made to specification.This is the only reported complaint for infiltration/extravasation of infuscate.Based on this evaluation, no conclusion could be drawn.We will continue to monitor for similar complaints and have notified the appropriate internal personnel.

Event Description

Five patients were receiving continuous titrated infusion of calcium chloride (cacl) in the pediatric intensive care unit (picu).The patient's were receiving extracorporeal membrane oxygenation (ecmo) and/or continuous renal replacement therapies (crrt) through a femoral central venous catheter when the user facility experienced difficulty.It was reported that a few days into use of the central venous catheters the clinician noticed burns at the insertion sites in all five patients.It was discovered that there had been infiltration/extravasation of the cacl infusate.The infusion was discontinued.The wounds were treated.Certain cases required interventional procedures with a vascular surgeon and/or plastic surgeon.

Manufacturer Narrative

Cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray.Foz catheter, intravascular, therapeutic, short-term less than 30 days.Lot # not provided by reporter.Catalog # not provided by reporter.Expiration date unknown as lot # is unknown.Udi # unknown as lot # is unknown.(b)(4).

Event Description

Five patients were receiving continuous titrated infusion of calcium chloride (cacl) in the pediatric intensive care unit (picu).The patient's were receiving extracorporeal membrane oxygenation (ecmo) and/or continuous renal replacement therapies (crrt) through a femoral central venous catheter when the user facility experienced difficulty.It was reported that a few days into use of the central venous catheters the clinician noticed burns at the insertion sites in all five patients.It was discovered that there had been infiltration/extravasation of the cacl infusate.The infusion was discontinued.The wounds were treated.Certain cases required interventional procedures with a vascular surgeon and/or plastic surgeon.

• Brand Name: UNK
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4808061
• MDR Text Key: 15566569
• Report Number: 1820334-2015-00325
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-UTLMY-501J-ABRM-HC-FST
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 21 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/14/2015
• Initial Date FDA Received: 05/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention