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

Catalog Number 2432-0007

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

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

Event Date 01/04/2023

Event Type  malfunction  

Event Description

It was reported that the bd alaris¿ pump module smartsite¿ infusion set was not secure causing it to leak.The following information was provided by the initial reporter: upon daily line changing of the patients continuous tpn and lipids the bedside nurse identified that the rubber stretchy section of iv tubing that sits in the pump module was not securely connected to the blue connecter piece above the stretchy section of the iv tubing.There was a slow drip of tpn fluid from this section of iv tubing.The bedside rn identified a puddle of what was identified as tpn fluid to on the floor of the patients' room that had not been identified prior to line changing.

Manufacturer Narrative

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

Manufacturer Narrative

The following fields were updated due to additional information: device available for eval yes, returned to manufacturer on: 26-jan-2023.Investigation summary one sample was received and tested by our quality team.The set was infused with saline solution and the leak at the top of silicone pump segment was immediately noticed.Under microscope there was a pinhole producing leak.Though the leakage was verified, the manufacturer has ensured that this was not due to assembly problems.The root cause of the leak is unknown.A device history record review for model 2432-0007 lot number 22045834 was performed.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.

Event Description

It was reported that the bd alaris¿ pump module smartsite¿ infusion set was not secure causing it to leak.The following information was provided by the initial reporter: upon daily line changing of the patient's continuous tpn and lipids the bedside nurse identified that the rubber stretchy section of iv tubing that sits in the pump module, was not securely connected to the blue connecter piece above the stretchy section of the iv tubing.There was a slow drip of tpn fluid from this section of iv tubing.The bedside rn identified a puddle of what was identified as tpn fluid to on the floor of the patients' room that had not been identified prior to line changing.

• 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: 16330804
• MDR Text Key: 309295963
• Report Number: 9616066-2023-00169
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403232329
• UDI-Public: 10885403232329
• 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: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2432-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2023
• 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
• Patient Age: 11 DA
• Patient Sex: Male