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 Problems Backflow (1064); Material Separation (1562)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/08/2023

Event Type  malfunction  

Manufacturer Narrative

D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Event Description

It was reported that during use with bd alaris pump module smartsite infusion set the iv line separated and blood back flowed.The following information was provided by the initial reporter: customer has reported that they have a very concerning issue with an iv set.The iv line became separated while connected to a patient and blood flowed back from patient.When the tubing separated the patient bled onto her bed linens.

Event Description

It was reported that during use with bd alaris pump module smartsite infusion set the iv line separated and blood back flowed.The following information was provided by the initial reporter: customer has reported that they have a very concerning issue with an iv set.The iv line became separated while connected to a patient and blood flowed back from patient.When the tubing separated the patient bled onto her bed linens.

Manufacturer Narrative

H6: investigation summary.One photo was received as sample and tested by our quality team.The separation between bottom of smartsite and tubing near male luer is evident and the customer's complaint has been verified.The manufacturing plant was notified of this failure and has confirmed a root cause: lack of solvent at a specific work bench where this portion of the set is assembled.There has been process reviews and work bench revisions performed since this set reached the final customer.The operators of this machine have been notified as well and this error has been significantly solved.A device history record review for model 2420-0007 lot number 23025295 was performed.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.

• 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: 17222314
• MDR Text Key: 318207884
• Report Number: 9616066-2023-01311
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: (01)07613203021012
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/13/2023

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 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
• Initial Date Manufacturer Received: 06/09/2023
• Initial Date FDA Received: 06/28/2023
• Supplement Dates Manufacturer Received: 07/13/2023
• Supplement Dates FDA Received: 08/01/2023
• 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