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 Difficult to Remove (1528)

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

Event Date 12/03/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.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 it was difficult to disconnect the device.There was no report of patient impact.The following information was provided by the initial reporter: on a current tri-fuse, concomitant medical product with heparin was connected and not able to unscrew off the tri-fuse.They attempted to remove by hand and with a rubber tipped kelly.The line was broken at the tri-fuse with a piece of alaris tubing stuck in the tri-fuse.

Manufacturer Narrative

H6: investigation summary: no product or photo was returned by the customer.The customer complaint of connection issues - unable to disconnect could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because the lot number is unknown.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

Event Description

It was reported while using bd alaris pump module smartsite infusion set it was difficult to disconnect the device.There was no report of patient impact.The following information was provided by the initial reporter: on a current tri-fuse, d10 with heparin was connected and not able to unscrew off the tri-fuse.They attempted to remove by hand and with a rubber tipped kelly.The line was broken at the tri-fuse with a piece of alaris tubing stuck in the tri-fuse.

• 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 ; 8015296192
• MDR Report Key: 16138923
• MDR Text Key: 308660856
• Report Number: 9616066-2022-02186
• 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: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• 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: 02/13/2023
• 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