MAUDE Adverse Event Report: COOK INC COOK TURBO-FLO HD HEMODIALYSIS CATHETER SET

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
International customer reported that the cook turbo-flo hd hemodialysis catheter was in use for treatment.Customer states "despite the forceps being closed the blood kept flowing." the customer reports that another catheter was needed.No further patient or event details were provided.The device was received by the manufacturer for evaluation.
Additional Manufacturer Narrative
Additional information: common device name: catheter, hemodialysis, non-implanted.Product code: mpb.510(k): k161504.Investigation ¿ evaluation: a review of the complaint history, drawing, device history record, documentation, instructions for use (ifu), quality control, and visual inspection/functional data of the returned device was conducted during the investigation.One catheter was returned with biomatter present on the distal end of the catheter.The manifold assembly was intact with the arterial and venous ports and clamps intact.The venous extension tubing was kinked because it had been clamped prior to shipping.Through the venous side, fluid was introduced into the catheter.Fluid went through the catheter with no leaks.The clamp was then activated on the venous side and fluid was introduced with a syringe using significant force and no fluid went through.Through the arterial side, fluid was introduced into the catheter.Fluid went through the catheter with no leaks.The clamp was then activated on the arterial side and fluid was introduced with a syringe and went through the catheter.This confirms the customer's complaint that blood kept flowing through the catheter after clamping it.There were no related nonconformances for the final product or any of the manifold subassemblies used in the final lot.To date, this is the only known complaint associated with this lot number.No visual damage to either the pinch clamp or extension tubing was observed in investigation of the returned product but the failure mode was duplicated.For this reason, the root cause is unknown.This is the only complaint on this product family for leaking clamp in the last three years and based on the associated severity of the failure, further risk reduction is not required at this time.We have notified the appropriate personnel and will continue to monitor for similar complaints.

• Brand Name: COOK TURBO-FLO HD HEMODIALYSIS CATHETER SET
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6636177
• Report Number: 1820334-2017-01405
• Device Sequence Number: 105913
• Product Code: MPB
• UDI-Device Identifier: 00827002350830
• UDI-Public: (01)00827002350830(17)181221(10)7327129
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-HDCS-1201J-LSC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/16/2017
• Supplement Date Received by Manufacturer: 11/03/2017
• Initial Report FDA Received Date: 06/13/2017
• Supplement Report FDA Received Date: 12/01/2017
• 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: Required Intervention