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

Model Number N/A

Device Problems Partial Blockage (1065); Use of Device Problem (1670)

Patient Problem No Code Available (3191)

Event Date 01/20/2020

Event Type  Injury  

Manufacturer Narrative

Device name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set.(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 after placement in the right femoral vein, the blue lumen of a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set was found to be occluded.Consequently, the physician "pump but doesn't have a blood".The occlusion was discovered right after device placement.Before the initial procedure, all lumens were filled with saline before introduction of the device into the patient.Nutrition medicine was being delivered through the device.The physician used saline to flush the unused lumen and then locked it.As part of hospital protocol, it was requested that heparinized saline not be used on a patient that had brain surgery.Ultimately, the patient required placement of a new device.No other adverse effects to the patient have been reported.

Event Description

It was originally reported that the device was placed in the right femoral vein, however the device was actually placed in the right subclavian vein.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation evaluation.It was reported that a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set (c-utlm-701j-rsc-abrm-hc-rd) from lot 9553215 was occluded right after device placement in the right subclavian vein.All lumens were flushed and unused lumens were filled with saline prior to introduction.Cook became aware of this event on (b)(6) 2020 upon being notified by national cheng kung university hospital.The patient reportedly experienced no adverse effects as a result of this incident.A review of documentation including the complaint history, device history record, instructions for use (ifu), manufacturing instructions and quality control, as well as a visual inspection and functional test of the returned device was conducted during the investigation.One used triple lumen central venous catheter was returned undamaged for evaluation.Three cook microclaves were returned, each attached to the hub.All three were able to be flushed with no issue.Biological matter was flushed out when the blue lumen was flushed.Additionally, a document-based investigation evaluation was performed.It was concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The risks associated with these devices are acceptable when weighed against the benefits.A review of the device history record for lot 9553215 and catheter subassembly lots found no related nonconformances that could have contributed to the failure mode.It should be noted that there were no other complaints reported for this lot number at the time of this investigation.There is no evidence to suggest that nonconforming product exists in house or in the field the instructions for use (ifu), provides the following information to the user related to the reported failure mode: suggested catheter maintenance.To prevent clotting or possibility of air embolus, the double-lumen¿s #2 lumen, the triple-lumen¿s #2 and #2 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.Based on the information provided, examination of the returned product and the results of our investigation, it was concluded that the patient condition potentially contributed to the event.It is likely that biological matter formed the reported occlusion, as regular saline was used as a lock.The customer stated that heparinized saline could not be used since the patient had brain surgery.The ifu recommends that unused lumens be maintained with a heparinized saline lock, not a regular saline lock.If heparinized saline was used, the occlusion could have been prevented.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.We 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: 9756889
• MDR Text Key: 192750665
• Report Number: 1820334-2020-00466
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002478299
• UDI-Public: (01)00827002478299(17)211219(10)9553215
• Combination Product (y/n): N
• PMA/PMN Number: K081113
• 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: 05/11/2020

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: 12/19/2021
• Device Model Number: N/A
• Device Catalogue Number: C-UTLM-701J-RSC-ABRM-HC-RD
• Device Lot Number: 9553215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Manufacturer Received: 02/13/2020
• Initial Date FDA Received: 02/26/2020
• Supplement Dates Manufacturer Received: 04/17/2020
• Supplement Dates FDA Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 76