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

Model Number G53599

Device Problem Complete Blockage (1094)

Patient Problems Fever (1858); Chills (2191); No Code Available (3191)

Event Date 01/27/2020

Event Type  Injury  

Manufacturer Narrative

Device name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set.(b)(6).(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 a the lumen of a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter was blocked, resulting in an interruption of treatment.The catheter was inserted on (b)(6) 2020 for improving nutrition.A "blocked 2nd catheter" was reported on (b)(6) 2020.The catheter was removed and a new catheter was placed in the right internal jugular vein within 72 hours.The replacement of the catheter resulted in an interruption of planned treatment.The patient was reported to have experienced fever, chills, and "rigor" due to this occurrence.Additional information regarding product and event details has been requested but is currently unavailable.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation ¿ evaluation.It was reported by dr.Jaya prakash from the department of anaesthesia & critical care from the asian institute of gastroenterology, india that a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter occluded after 48 hours.The patient was a 33-year-old male who weighed 68 kilograms.He had been diagnosed with pancreatic necrosis.A pancreatic necrosectomy had been planned.It was also reported that the patient was ¿in sick condition with sepsis requiring long term venous access.¿ the complaint device was inserted on (b)(6) 2020 to improve the patient¿s nutrition.This catheter became occluded.A new catheter was placed on (b)(6) 2020 in the right internal jugular vein.It was reported that adverse patient effects included fever with chills and rigor.It is assumed that this was due to an interruption of antipyretic and antibiotic medications to address the sepsis.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control was conducted during the investigation.The complaint device was not returned for evaluation so no device examination could be performed.Additionally, a document based investigation evaluation was performed.A review of the device master record found that proper procedures are in place to identify and prevent this failure mode prior to device distribution.A review of the design history file found that the risks associated with the devices are acceptable when weighed against the benefits.A review of the device history record found one relevant nonconformance for which all nonconforming product was scrapped.No additional complaints have been received from the field for this device lot.There is no evidence to suggest there is any nonconforming product in house or out in the field.A review of the product labeling for the device was completed.The instructions for use state the following instructions related to the reported failure mode: suggested lumen utilization: triple-lumen: ¿#1 distal exit port (end hole) ¿ whole blood or blood product delivery and sampling; any situation requiring more flow rate; cvp monitoring; medication delivery; power injection studies.It is strongly recommended that this lumen be used for all blood sampling.¿ct¿ labeled on the distal #1 lumen hub indicates that this is the lumen which should be utilized for power injection.#2 middle exit port ¿ medication delivery; acute hyperalimentation #3 proximal exit port ¿ medication delivery.¿ suggested catheter maintenance: ¿to prevent clotting or possibility of air embolus, the double-lumen¿s #2 lumen, the triple-lumen¿s #2 and #3 lumens, and the five-lumen¿s #2, #3, #4, and #5 lumens should be filled with saline solution or heparinized saline solution (100 units of heparin per ml of saline is usually adequate), depending on institutional protocol, prior to catheter introduction.Any unused lumens should be maintained with continuous saline or heparinized saline drip or locked with heparinized saline solution.Before using any lumen already locked with heparin, lumen should be flushed with twice the indicated lumen volume using normal saline.Lumens should be flushed with normal saline between administrations of different infusates.After use, lumen should again be flushed with twice the indicated lumen volume using normal saline before reestablishing heparin lock.¿ how supplied: ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, no inspection of the product, and the results of the investigation, a definitive cause was established as component failure without a manufacturing or design deficiency.The appropriate personnel have been notified.Per the quality engineering risk assessment, no further action is required.Cook will continue to monitor for similar complaints.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 SPECTRUM
• Type of Device: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9693193
• MDR Text Key: 190557552
• Report Number: 1820334-2020-00324
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002535992
• UDI-Public: (01)00827002535992(17)220213(10)NS9597533
• Combination Product (y/n): N
• PMA/PMN Number: K033843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 04/16/2020

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 Expiration Date: 02/13/2022
• Device Model Number: G53599
• Device Catalogue Number: C-UTLM-701J-ABRM-HC-RD-P
• Device Lot Number: NS9597533
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/27/2020
• Initial Date FDA Received: 02/11/2020
• Supplement Dates Manufacturer Received: 04/13/2020
• Supplement Dates FDA Received: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Weight: 68