MAUDE Adverse Event Report: CAREFUSION AS LVP 20D 3SS CV; SET, ADMIN, INTRAVASCULAR

Model Number 2426-0007

Device Problems Leak/Splash (1354); Device Damaged Prior to Use (2284); Improper Flow or Infusion (2954)

Patient Problem No Patient Involvement (2645)

Event Date 07/08/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that as lvp 20d 3ss cv y-site is missing from the tubing.The following information was provided by the initial reporter: material no: 2426-0007, batch(lot) no: 20046950.It was reported that the y-site is missing from tubing.We have a batch of defective tubing 2426-0007.The y site below the back check valve is missing.Staff have tossed at least 6 sets since they can¿t attach the short set.

Manufacturer Narrative

It was reported that customer ordered material from model 2426-0007 and received a set of the model 2420-0007 inside of 2426-0007 pouch, with lot number 20046950.Customer complaint was confirmed through pictures provided by the customer and confirmation of the sample by cad sd.After a mapping process was performed and the review of the timeline, the potential root cause identified for this failure mode is material mixed in rework of packaging.The model 2426-0007 was built in the line 27 and the model 2420-0007 in the line 28.In this time the conveyors of the lines did not have guards in the connection between conveyors.Guards were placed on conveyors on june 23rd, 2020 to avoid mixed of material between lines near (qn (b)(4)), although on the shore of each side of conveyor has not guards implemented then sometimes the sets could fall from conveyors to floor and the material handler must place the set inside another pouch and made it easier for the material to be mixed.The guards on the shore of each side of the conveyors will be implemented on september 23rd, 2020 by the production/process, to prevent the parts falling from the conveyors and avoid carry out reworks during the production process.A device history record review for model 2426-0007 lot number 20046950 was performed.The search showed that a total of 34,563 units in 1 lot number was built on 29april2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

Event Description

It was reported that as lvp 20d 3ss cv y-site is missing from the tubing.The following information was provided by the initial reporter: material no: 2426-0007 batch(lot) no: 20046950 it was reported that the y-site is missing from tubing.We have a batch of defective tubing 2426-0007.The y site below the back check valve is missing.Staff have tossed at least 6 sets since they can¿t attach the short set.

• Brand Name: AS LVP 20D 3SS CV
• Type of Device: SET, ADMIN, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10336438
• MDR Text Key: 202218629
• Report Number: 9616066-2020-02250
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• UDI-Public: 10885403227998
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/29/2023
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: 20046950
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 20200708; 20200708
• Patient Outcome(s): Other