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

Model Number 2426-0007

Device Problem Material Separation (1562)

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

Event Date 08/02/2022

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 the components separated and leaked.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that the " iv tubing falling apart at drip chamber".I am submitting another report for iv tubing falling apart at drip chamber.Malfunction of bag connection to iv spike - reported by or rn and anesthesiologist spike fell out of fentanyl bag.Contents of bag reported as spilling on the floor.Upon arrival back to room.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, returned to manufacturer on: 15-aug-2022.H6: investigation summary: a used 2426-0007 set and an iv bag were received and tested by our quality team.The iv bag was taped off and the port where drip chamber was to be inserted was not accessible.The bag not a bd/ carefusion product.The bag was infused with saline using a bd iv bag and no issue was realized.The set was visually analyzed and there was no problem noticed.The leakage could not be verified and the root cause remains unknown.It is highly likely that the issue is with the iv bag used with the infusion set.A device history record review could not be performed because a lot number was not provided by the customer.

Event Description

It was reported while using bd alaris pump module smartsite infusion set the components separated and leaked.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that the " iv tubing falling apart at drip chamber".I am submitting another report for iv tubing falling apart at drip chamber malfunction of bag connection to iv spike - reported by or rn and anesthesiologist spike fell out of fentanyl bag.Contents of bag reported as spilling on the floor.Upon arrival back to room.

• 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: 15324367
• MDR Text Key: 305376009
• Report Number: 9616066-2022-01248
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• UDI-Public: 10885403227998
• 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: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2022
• 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