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

Model Number 2420-0007

Device Problem Separation Failure (2547)

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

Event Date 01/30/2023

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd alaris pump module smartsite infusion set the device was difficult to disconnect and broke.There was no report of patient impact.The following information was provided by the initial reporter: rn strung new iv fluids with alaris tubing for dextrose fluids and attempted to remove old line.After unsuccessful attempt, second rn attempted at bedside without success.3rd rn attempted to remove with rubber tipped clamps and male end of tubing snapped and remained inside tri-fuse.

Event Description

It was reported while using bd alaris pump module smartsite infusion set the device was difficult to disconnect and broke.There was no report of patient impact.The following information was provided by the initial reporter: rn strung new iv fluids with alaris tubing for dextrose fluids and attempted to remove old line.After unsuccessful attempt, second rn attempted at bedside without success.3rd rn attempted to remove with rubber tipped clamps and male end of tubing snapped and remained inside tri-fuse.

Manufacturer Narrative

Investigation summary: the customer reported the luer tip broke off, and returned one photo of the incident.The photo verifies the complaint.The root cause cannot be determined without the physical sample for investigation.A device history record review could not be performed on material 2420-0007 because the lot number is unknown.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16440330
• MDR Text Key: 310245742
• Report Number: 9616066-2023-00268
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203021020
• UDI-Public: (01)37613203021020
• 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: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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