MAUDE Adverse Event Report: BECTON DICKINSON AS LVP 20D DEHP 3SS CV; INTRAVENOUS EXTENSION TUBING SET

Catalog Number 2426-0500

Device Problem Stretched (1601)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2024

Event Type  malfunction  

Event Description

Material#: 2426-0500 batch number#: unknown it was reported by customer that pump module was infusing amiodarone at 600ml/hr, and subsequently programmed down to 33.3ml/hr.It was noted the infusion had many occlusion alarms, prior to having a "flow block alarm" at 15:17.The tubing was noted to have ballooned in the channel at the upper fitment area.Note on pump said ¿channel doesn¿t work properly.This was reported to bd representatives during site visit.There was patient involvement but no harm.Rcc received a complaint via email.Email(s) attached amiodarone infused at 600ml/hr.And then went down to 33.3ml/hr.Devices pcu 14149001 lvp 16135024 and primary tubing ref (b)(4) (likely but need to confirm with customer) with add on filter extension set ref (b)(4) sequestered in biomed.Tubing ballooned in channel during infusion around the upper fitment area.Note on pump said, ¿channel doesn¿t work properly¿.Infusion had many occlusion alarms before having a ¿flow block alarm¿ at 15:17.Cpc discussed occlusion troubleshooting with clinical (did not speak to the nurse who had the event), clinicians said they would not normally give an iv push at a lower smartsite to check for patency.They would normally detach the tubing and flush right at the vad.They may use the upper smartsite to remove air from the line, but not to push anything in.Cpc discussed prevention of ballooning, but no practices reported onsite were found to be potential contributing factors to the reported event.Customer encouraged to send device and tubing to bd for investigation.Per pharmacy amiodarone is compounded manually into a 500ml baxter iv bag.No patient harm reported.

Manufacturer Narrative

(b)(4) : initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

• Brand Name: AS LVP 20D DEHP 3SS CV
• Type of Device: INTRAVENOUS EXTENSION TUBING SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MDS DCHU; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18969379
• MDR Text Key: 338663696
• Report Number: 9616066-2024-00462
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203021006
• UDI-Public: (01)37613203021006
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2426-0500
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1