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

Catalog Number 20129E

Device Problems Complete Blockage (1094); Defective Component (2292)

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

Event Date 01/08/2024

Event Type  malfunction  

Manufacturer Narrative

B3.The date received by manufacturer has been used for this field.E1: initial reporter facility name- (b)(6) specialists.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd alaris extension set was occluded.The following information was received by the initial reporter with the verbatim: item description: tube iv ext w/ filter 1.2 mi lawson# (b)(4).Mfg# 20129e lot#(10)23109126 qty: (b)(4).Description of problem: malfunctioning filter.Pumped alarmed as patient side occluded, filter not infusing.Customer account #(b)(6).Please initiate the return and credit.Also make sure to use our choc report number for all communication.

Manufacturer Narrative

It was reported by customer that malfunctioning filter.Pumped alarmed as patient side occluded, filter not infusing.No product or photo was returned by the customer.The customer complaint of flow issue - accuracy could not be verified due to the product not being returned for failure investigation.See the attached ¿filtering out the facts: recommendations to optimize performance of in-line filters for parenteral nutrition and intravenous fat emulsion infusions (ivfe)¿ for additional information regarding the use of ivfe with in-line filter administration sets.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.A device history record review for model 20129e lot number 23109126 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on (b)(6) 2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

No additional information was provided.Material#: 20129e.Batch#: (10)23109126.It was reported by customer that malfunctioning filter.Pumped alarmed as patient side occluded, filter not infusing.Verbatim: rcc received a complaint via email.Email(s) attached.Item description: tube iv ext w/ filter 1.2 mi lawson# 221308.Mfg# 20129e.Lot#(10)23109126.Qty: 1 ea.Po #(b)(4).Description of problem: malfunctioning filter.Pumped alarmed as patient side occluded, filter not infusing.Customer account # (b)(4).Please initiate the return and credit.Also make sure to use our choc report number for all communication.

• Brand Name: BD ALARIS EXTENSION 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18592979
• MDR Text Key: 335076724
• Report Number: 9616066-2024-00091
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403234901
• UDI-Public: (01)50885403234901
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K790108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

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: 20129E
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 01/28/2024
• Supplement Dates Manufacturer Received: 03/11/2024
• Supplement Dates FDA Received: 03/18/2024
• 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