MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS PUMP INFUSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number 2426-0500

Device Problems Complete Blockage (1094); Restricted Flow rate (1248); Leak/Splash (1354); Infusion or Flow Problem (2964)

Patient Problem Not Applicable (3189)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

Multiple catalog & lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device catalog #: 2426-0500, medical device lot #: 20013117, medical device expiration date: 2023-01-13, device manufacture date: 2020-01-09.Medical device catalog #: unknown, medical device lot #: unknown, medical device expiration date: unknown, device manufacture date: unknown.The initial reporter also notified the fda on 13 april, 2020.Medwatch report # mw5093988.Report source other: medwatch report.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that bd alaris pump infusion set tubing was damaged, leaked, blocked, and had large bubbles.This occurred on 3 occasions.The following information was provided by the initial reporter: event 1: material no: unknown, batch no: unknown.It was reported that tubing was "sliced" and leaking after tubing had been running for multiple hours.Event 2: material no: 2426-0500, batch no: 20013117.It was reported that new tubing noted to be "blocked" and large bubble created along the tubing that is in the arm of the iv pump.Event 3: material no: unknown, batch no: unknown.It was reported that iv pump tubing was leaking and a had a hole in the tubing with another tpn infusion.Event description per email states: "iv tubing in pump noted to be "sliced" and leaking after tubing had been running for multiple hours (no package info for this tubing) tubing changed then, new tubing noted to be "blocked", and large bubble created along tubing that is in the arm of the iv pump second regular iv tubing set (bubble) packaging info bd alaris pump infusion set, ref (b)(4), lot (10) 20013117, exp 01/13//2023 we recently had another issue with iv pump tubing leaking/ having a hole in the tubing with another tpn infusion no package info for this tubing fda safety report id # (b)(4)".

Event Description

It was reported that bd alaris pump infusion set tubing was damaged, leaked, blocked, and had large bubbles.This occurred on 3 occasions.The following information was provided by the initial reporter: event 1: material no: unknown; batch no: unknown.It was reported that tubing was "sliced" and leaking after tubing had been running for multiple hours.Event 2: material no: 2426-0500; batch no: 20013117.It was reported that new tubing noted to be "blocked" and large bubble created along the tubing that is in the arm of the iv pump.Event 3: material no: unknown; batch no: unknown.It was reported that iv pump tubing was leaking and a had a hole in the tubing with another tpn infusion.Event description per email states: "iv tubing in pump noted to be "sliced" and leaking after tubing had been running for multiple hours (no package info for this tubing) tubing changed then, new tubing noted to be "blocked", and large bubble created along tubing that is in the arm of the iv pump second regular iv tubing set (bubble) packaging info bd alaris pump infusion set, ref (b)(4), lot (10) 20013117, exp 01/13//2023 we recently had another issue with iv pump tubing leaking/ having a hole in the tubing with another tpn infusion no package info for this tubing fda safety report id # (b)(4)".

Manufacturer Narrative

H.6.Investigation: no product or photo was returned by the customer.A device history record review could not be performed because a model or lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

• Brand Name: BD ALARIS PUMP INFUSION SET
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244 ; MX 22244
• MDR Report Key: 10646209
• MDR Text Key: 242381464
• Report Number: 9616066-2020-20034
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203021006
• UDI-Public: 37613203021006
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2426-0500
• Device Catalogue Number: SEE H.10
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 10/14/2020
• Supplement Dates FDA Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other