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

Model Number 2426-0500

Device Problem Backflow (1064)

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

Event Date 12/31/2022

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 alaris pump module smartsite infusion set backflow and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: detail: d51/2ns + 40 meq potassium ivf was back flowing through the tubing and out of the most proximal port and dripping onto sheets.Sample available.Number of occurrences: 1.0.

Event Description

It was reported while using alaris pump module smartsite infusion set backflow and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: detail: d51/2ns + 40 meq potassium ivf was back flowing through the tubing and out of the most proximal port and dripping onto sheets.Sample available.Number of occurrences: 1.0.

Manufacturer Narrative

H.6.Investigation: one sample was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.Sample was primed with normal saline, a bd secondary set was primed with blue dye water and attached to the primary set.The sets were allowed to flow, no observation of back flow was observed.The customer complaint that potassium was back flowing through the tubing and out of the most proximal port could not be replicated.The root cause could not be determined because the issue could not be replicated.A device history record review could not be performed because a lot number was not provided by the customer.H3 other text : see h.10.

• Brand Name: 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: 13343265
• MDR Text Key: 286676319
• Report Number: 9616066-2022-00022
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203021006
• UDI-Public: 37613203021006
• 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: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2426-0500
• Device Catalogue Number: 2426-0500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2022
• 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