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

Catalog Number 2426-0007

Device Problem Material Deformation (2976)

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

Event Date 06/29/2023

Event Type  malfunction  

Manufacturer Narrative

D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.3.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 tubing bulged and expanded.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by customer that the tubing bubbled on them."the nurse was priming the tubing when this occurred.No leakage just wouldn't prime the tubing, we have no batch #, the incident happened before use on the patient.No harm to the patient, gathered new tubing and hooked the patient up to iv with no problem with the 2nd set of tubing".

Event Description

It was reported while using bd alaris pump module smartsite infusion set the tubing bulged and expanded.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by customer that the tubing bubbled on them."the nurse was priming the tubing when this occurred.No leakage just wouldn't prime the tubing, we have no batch #, the incident happened before use on the patient.No harm to the patient, gathered new tubing and hooked the patient up to iv with no problem with the 2nd set of tubing".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 10-jul-2023.Investigation summary: one sample model 2426-0007 arrived for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was primed and an infusion run was performed at a rate of 125 ml/hr for 1 hour.No bulge in the silicone segment was observed.The customer complaint that the tubing bubbled 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.

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17417768
• MDR Text Key: 320616203
• Report Number: 9616066-2023-01569
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• UDI-Public: (01)10885403227998
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: 09/06/2023
• 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