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

Catalog Number C-HDCSYJ-1201J-LSC-IHI-CCT-A

Device Problem Crack (1135)

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 instances of catheters cracking down the extension tubing on either the access or return line.The report with mfg.Report reference #: 1820334-2020-00105 references the instances of catheters that have cracked at the hub.Additional information regarding the patients, events, and devices has been requested but is unavailable at the time of this report.

Event Description

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

Manufacturer Narrative

Investigation - evaluation: it was reported that three cook turbo-flo hd hemodialysis catheter trays (c-hdcsyj-1201j-lsc-ihi-cct-a) cracked along the extension tubes.Further communication with the user facility clarified that the double lumen catheters are cracking while patients are on continuous renal replacement therapy (crrt), allowing air to be drawn into the machine.The device needed to be removed, another line needed to be placed, and the patient needed to be placed back on the machine in each case.Cook became aware of this event on (b)(6) 2020 upon being notified by royal columbian hospital.There was no information provided about additional potential adverse effects due to this event.Mdr reference # 1820334-2020-00105 addresses the catheters cracking at the hub reported by the same user facility.A review of the complaint history, device history record (dhr), instructions for use (ifu), and quality control 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 file found that the risks associated with these devices are acceptable when weighed against the benefits.While the user facility did not provide a lot number, cook was able to narrow down two potential lots for this device based upon sales records to the user facility.A review of the dhrs for these two lots revealed no recorded non-conformances.A database search found no other events associated with either potential lot.Since there are no related non-conformances or other complaints from the two potential set lots, there is no evidence that nonconforming product exists in house or in the field.Additionally, based on the given information, cook has concluded that this device was manufactured to specification.Cook also reviewed product labeling.Instructions for use (ifu) document t_hdcsdry_rev1 [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.Flow rate vs pressure this table describes average maximum pressure based on flow rate.Suggested catheter maintenance prior to catheter insertion both distal and proximal lumens should be filled with normal saline solution or heparinized saline solution, depending on institutional protocol.After catheter is placed and prior to use, tip position and lumen patency should be confirmed by free aspiration of venous blood.If blood is not freely aspirated, the physician should immediately reevaluate catheter tip position.Before using any lumen already locked with heparin, the lumen should be aspirated.After use, the lumen should again be flushed with normal saline to prevent systemic heparinization before reestablishing heparin lock.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 the investigation, a root cause was traced to component failure without a manufacturing or design deficiency.It is possible that use conditions, such as inadvertent stress on the devices, contributed to the failures, though this was not confirmed.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.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.

• Brand Name: COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9586706
• MDR Text Key: 188857515
• Report Number: 1820334-2020-00106
• 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: 05/05/2020

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 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: 04/20/2020
• Supplement Dates FDA Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention