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

Model Number	G35083
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Blood Loss (2597)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common name: catheter, hemodialysis, non-implanted.Procode: mpb.A 510k #: k161504.(b)(4).The event is currently under investigation.A follow-up report will be submitted following the completion of the complaint investigation.
Event or Problem Description
It was reported the venous line of a turbo-flo hd hemodialysis catheter did not close properly, which resulted in some drops of blood loss despite it being clamped.During the initial insertion of the catheter, before correct placement was confirmed, the 2 lumens were clamped off leaving only the connector free.At this time, the catheter was observed to be leaking blood and not functioning as intended.The catheter remained in place and its removal date is unknown.Additional information regarding the event and current patient status is unknown.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection/dimensional verification and functional test of the returned device were conducted during the investigation.Clinical assessment: photos of the device show the device unclamped and without any injection caps.It is not known if injection caps were placed on the device after placement.Per the ifu, ¿prepare the catheter for insertion by flushing each of the lumens with normal saline, and clamp the proximal extension.Attach the injection cap to the proximal extension.Leave the distal extension uncapped for wire guide passage.¿ then, ¿after the catheter is in position, remove the wire guide and inner obturator.Venous blood should be easily aspirated.Each lumen should be capped and locked with solution based on specific hospital policy or protocol.¿ it is assumed that use of forceps may actually be referencing the clamps and not actual forceps.However, if forceps were used to clamp the device instead of hemostats it is unlikely they could completely clamp the device.There is no information regarding the use of heparin that may have contributed to this event.The amount of blood loss would depend on frequency of patient monitoring.The failed clamp could potentially result in either significant blood loss or an air embolus resulting in severe harm.Routine flushing and devices to flush the device is not known.Without understanding whether the injection caps were placed on the device, it is difficult to conclude the cause of this event.There is no information stating the patient removed the injection caps.Therefore, the clinical assessment cannot eliminate any possible causes for this event such as medical procedure, user technique, heparin use, failure to follow ifu, device maintenance, device failure, or manufacturing related causes.The device was returned and an analysis was performed.When a leak test was performed using water during the functional evaluation of the device, the leak was discovered to be coming from the extension tubes at the side ports with the red hubs.No leakage was noted from the extension tube of the blue hub.The visual inspection of the device confirmed that the outer diameter of the extension tube measured within specification.Although the failure could be duplicated, there was no damage noted to the plastic clamps.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints and will notify appropriate personnel.Per the quality engineering risk assessment, no further action is required.

• Brand Name: COOK TURBO-FLO HD HEMODIALYSIS CATHETER SET
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7484700
• Report Number: 1820334-2018-01210
• Device Sequence Number: 160256
• Product Code: MPB
• UDI-Device Identifier: 00827002350830
• UDI-Public: (01)00827002350830(17)190509(10)7828353
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2018

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: G35083
• Device Catalogue Number: C-HDCS-1201J-LSC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 05/31/2018
• 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