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

Catalog Number 2420-0500

Device Problem Component Missing (2306)

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

Event Date 05/05/2023

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot #: 23013083.D4.Medical device expiration date: 16jan2026.H4.Device manufacture date: 11jan2023.D.4.The reported lot number [22126249] was reported, however, this is not a lot # manufactured for the reported catalog #[2420-0500 ].E.4.Fda notified: the initial reporter also notified the fda via medwatch# [4901170000-2023-8001].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 was missing a component.The following information was received by the initial reporter with the verbatim: the roller clamp was missing on a bd alaris pump infusion set back check valve packages.Lot # (10)23013083 & (10)22126249.What was the original intended procedure? : to infuse a medication to the patient from the iv pump.What problem did the user have (check all that apply) :device malfunction - that is, the device did not do what it was supposed to do.

Event Description

No additional information was provided.

Manufacturer Narrative

The customer returned one sample of material 2420-0500 and two potential lots 23013083; 22126249.The sample was visually inspected and the customer complaint that there is no roller clamp was verified.The set had no other defects detected.Device history record review for model 2420-0500 lot number 22126249 was performed.The search showed no information, the lot and material must be a bad combination, or a typo.The probable root causes were traced to manufacturing error with personnel and also the tubing humidification process.The personnel involved were notified of the failure.

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17887034
• MDR Text Key: 325120079
• Report Number: 9616066-2023-02013
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203012448
• UDI-Public: (01)37613203012448
• 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,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2023

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: Health Professional
• Device Catalogue Number: 2420-0500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 10/06/2023
• Supplement Dates Manufacturer Received: 11/22/2023
• Supplement Dates FDA Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1