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 Backflow (1064)

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

Event Date 01/24/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that blood back-flowed from the bd alaris¿ pump module smartsite¿ infusion set tubing into the bag instead of the pump.The following information was provided by the initial reporter: "secondary tubing flow not flowing into pump tubing but backing up into the bag.".

Manufacturer Narrative

The following fields were updated due to additional information: d4: medical device lot #: 22105672.D4: medical device expiration date: 25oct2025.H4: device manufacture date: 25oct2022.D4: medical device lot #: 22109215.D4: medical device expiration date: 12oct2025.H4: device manufacture date: 12oct2022.D10: device available for eval yes.D10: returned to manufacturer on: 13-feb-2023.H6: investigation summary two samples of material 2420-0007 and 3 of material ms3500-15 were returned for investigation under pr 7017167.Through visual inspection, no defects or damages were observed on the sets.These were then primed and infused, with no backflow issues observed.The defect could not be replicated.The device history review was completed for the returned samples lots.The device history review was completed for the returned samples lots.The device history review was completed for the returned samples lots.Due to the failure not being able to be replicated, a root cause could not be determined.

Event Description

It was reported that blood back-flowed from the bd alaris¿ pump module smartsite¿ infusion set tubing into the bag instead of the pump.The following information was provided by the initial reporter: "secondary tubing flow not flowing into pump tubing but backing up into the bag.".

• 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: 16375228
• MDR Text Key: 309598412
• Report Number: 9616066-2023-00206
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 07613203021012
• 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: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• 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: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: BD ALARIS¿ SECONDARY SET