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

Model Number N/A

Device Problems Crack (1135); Fitting Problem (2183)

Patient Problem No Code Available (3191)

Event Date 11/20/2019

Event Type  Injury  

Manufacturer Narrative

Common name: catheter, hemodialysis, non-implanted.Product code: mpb.(b)(6).Occupation: unknown.Pma/510(k) #: k161504.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that cook turbo-flo hd hemodialysis catheter tray catheters are either cracking at the hub or down the extension tubing on either the access or return line.The user facility has reported that this has occurred at least six times.Patients using these devices are on continuous renal replacement therapy (crrt).The machines used with these devices are "ringing off 'air in blood' alarm" and are reportedly drawing air into the machine as a result of catheter failure.Consequently, the patients have "needed to be taken off the prismaflex, rewired for another line and then put back on the machine".It was stated that "this is a safety issue with air entering the machine".The patients have reportedly experienced delayed treatment as they had to be re-placed on the machine once another line was inserted.This report references the catheters that have cracked at the hub.The report with patient id: (b)(6) references the instances of catheters cracking down the extension tubing on either the access or return line.Additional information regarding the patients, events, and devices has been requested but is unavailable at the time of this report.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable or unchanged.Investigation - evaluation it was reported that three cook turbo-flo hd hemodialysis catheter trays (c-hdcsyj-1201j-lsc-ihi-cct-a) were cracking at the hub while patients are on continuous renal replacement therapy (crrt), allowing air to be drawn into the machine.The devices needed to be removed, another line needed to be placed, and the patient needed to be placed back on the machine.Cook became aware of this event on (b)(6) 2019 upon being notified by royal columbian hospital.There was no information provided about additional potential adverse effects due to this event.A review of the documentation including the complaint history, device history record (dhr), instruction for use (ifu) and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient controls are in place to detect this failure mode prior to release.A review of the design history files for this device found that this product is both safe and effective for its intended use.Thought the lot number was not provided by the user facility, cook was able to narrow down the potential lot number for this device to either ns7697795 or ns9005561.A review of the dhrs for these lots as well as related sub-assembly lots revealed no non-conformance's related to this failure mode.A database search did not find any other reported events associated with either of these lots.Since there are no related non-conformance's or other complaints from the two potential set lots, there is no evidence that nonconforming product exists in house or in the field.Additionally, with the available information, cook has concluded that this product was manufactured to specification.Cook also reviewed product labeling.Instructions for use (ifu) document for cook turbo-flo® hd acute hemodialysis catheter is packaged with this device.The product ifu states the following in consideration of the reported failure mode: ¿warnings ¿ do not use if the packaging or product has been compromised by physical damage.Precautions ¿ if lumen flow is impeded, do not force injection or withdrawal of fluids.How supplied ¿ upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, no product returned, and the results of our investigation, a definitive root cause could not be established.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Appropriate measures are being taken to address this failure mode.Corrective and preventative action has been initiated to address this failure mode for this device and its device family.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9586529
• MDR Text Key: 188494230
• Report Number: 1820334-2020-00105
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/18/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-HDCSYJ-1201J-LSC-IHI-CCT-A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/22/2019
• Initial Date FDA Received: 01/14/2020
• Supplement Dates Manufacturer Received: 03/10/2020
• Supplement Dates FDA Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention