MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ LVP 20D DEHP 2SS CV; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 2420-0500

Device Problem Defective Device (2588)

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

Event Date 12/19/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 2 of the bd alaris¿ lvp 20d dehp 2ss cv bubbled out during normal use of medication delivery.The following information was provided by the initial reporter: i have 2 alaris tubing sets #2420-0500 from lot #(10) 22103003 that developed "bubbled out like an aneurysm" during normal use of medication delivery.

Event Description

It was reported that 2 of the bd alaris¿ lvp 20d dehp 2ss cv bubbled out during normal use of medication delivery.The following information was provided by the initial reporter: i have 2 alaris tubing sets #2420-0500 from lot #(10) 22103003 that developed "bubbled out like an aneurysm" during normal use of medication delivery.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 08-feb-2023.H6: investigation summary: two photos and two samples were submitted for quality investigation.The customer complaint of tubing defective was verified by review of the photos provided.Evaluation of the photos provided show that a large bubble formed at the top of the silicone tubing of the pumping segment.Investigation of the samples submitted began with a visual examination of the infusion sets for damage or defects.No visible damages or defects were identified on the samples.The samples were then primed and a simulated infusion was conducted in order to attempt to replicate the ballooning seen in the silicone pumping segment.The pumps were to flow at a rate of 400 ml/hr and were allowed to flow for 30 minutes.Intermittent checking of the silicone pumping segment was conducted every 10 minutes.Ballooning of the silicone pumping segment could not be replicated.No other issues were identified during testing.A device history record review for model 2420-0500 lot number 22103003 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the failure could not be determined because the failure could not be replicated.The probable root cause is an incorrect use of the infusion set by the operator.

• Brand Name: BD ALARIS¿ LVP 20D DEHP 2SS CV
• 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16134225
• MDR Text Key: 308545886
• Report Number: 9616066-2022-02181
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203012430
• UDI-Public: 07613203012430
• 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: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2023

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 Catalogue Number: 2420-0500
• Device Lot Number: 22103003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2022
• Initial Date FDA Received: 01/10/2023
• Supplement Dates Manufacturer Received: 02/09/2023
• Supplement Dates FDA Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1