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

Catalog Number 2420-0007

Device Problem Material Separation (1562)

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

Event Date 10/23/2023

Event Type  malfunction  

Manufacturer Narrative

H3.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 bd alaris pump module smartsite infusion set separated.The following information was received by the initial reporter with the verbatim: product bd: product no.: lot no.: alaris lvp 20d 2ss cv iv pump infusion sets 2420-0007 (10) 23025193, (10) 23075292 secondary administration sets, non-vented needle-free valve, bag access port, roller clamp(s), texium closed male luer with hanger 10013364t (10) 23059177, (10) 23039137 manufacturer(s): bd.Problem: 1.The tubing in bd primary and secondary iv administration sets may separate from the drip chamber.Sets from the following lots have exhibited this problem: a.Primary sets product number 2420-0007, lot numbers: (10) 23025193, (10) 23075292.B.Secondary sets product number 10013364t, lot numbers: (10) 23059177, (10) 2303913.2.When this occurs: a.Medication may spill, potentially exposing staff and patients to toxic medication such as chemotherapy agents.B.Treatment may be delayed.

Manufacturer Narrative

It was reported by customer that the tubing in bd primary and secondary iv administration sets may separate from the drip chamber.Medication may spill.No product or photo was returned by the customer.The customer complaint of separation other component - leak could not be verified due to the product not being returned for failure investigation.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 2420-0007, lot number 23025193 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 11feb2023.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.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.H3 other text : see narrative below.

Event Description

No additional information for provided.Material #: 2420-0007, batch #: 23025193, 23075292.It was reported by customer that the tubing in bd primary and secondary iv administration sets may separate from the drip chamber.Medication may spill.Verbatim: product bd: product no.: lot no.: alaris lvp 20d 2ss cv iv pump infusion sets 2420-0007 (10) 23025193, (10) 23075292, secondary administration sets, non-vented needle-free valve, bag access port, roller, clamp(s), texium closed male luer with hanger, 10013364t (10) 23059177, (10) 23039137.Manufacturer(s): bd.Problem: 1.The tubing in bd primary and secondary iv administration sets may separate from the drip chamber.Sets from the following lots have exhibited this problem: a.Primary sets product number 2420-0007, lot numbers: (10) 23025193, (10) 23075292.B.Secondary sets product number 10013364t, lot numbers: (10) 23059177, (10) 2303913.2.When this occurs: a.Medication may spill, potentially exposing staff and patients to toxic medication such as chemotherapy agents.B.Treatment may be delayed.Response received 08 nov 2023.We did not have an issue with this.We were just inquiring about this.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE 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
• 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: 18086484
• MDR Text Key: 327611266
• Report Number: 9616066-2023-02158
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: (01)07613203021012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

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: 2420-0007
• Device Lot Number: 23075292
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 01/03/2024
• Supplement Dates FDA Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1