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

Catalog Number 10013902

Device Problem Break (1069)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 12/28/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device evaluated by mfr: 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 2 bd alaris¿ smartsite¿ low sorbing sets broke when attached to their patients during use.The following information was provided by the initial reporter: "in the past two days we have had two add on 0.2 micron filters al10013902 break while attached to patients in our nicu.This is the add-on filter that was recommended to us as a replacement for al 20350e".

Manufacturer Narrative

The following fields were updated due to additional information: d4: medical device lot #: 22069109.D4: medical device expiration date: 06jun2025.H4: device manufacture date: 06jun2022.D4: medical device lot #: 22069110.D4: medical device expiration date: 07jun2025.H4: device manufacture date: 07jun2022.D10: device available for eval yes.D10: returned to manufacturer on: 11jan-2023.H6: investigation summary two samples of material number 10013902 were submitted by the customer for quality evaluation.The customer complaint of component damaged - no leak was not verified based on the investigation of the sample, however, the samples submitted showed signs of separation of the extension set tubing to the outlet port of the drip chamber.Further investigation of the location under magnification indicates a lack of solvent at the union location.A device history record review for model 10013902 lot number 22069109 was performed.The search showed that a total of 17,603 units in 1 lot number was built on 06jun2022 there were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 10013902 lot number 22069110 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 07jun2022 there were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for issues seen in the samples received is that the tubing was connected to the filter without using any fixture to ensure the correct connection.As a result there is a variation in the execution of the assembly operation causing for the lack of solvent at the union location.

Event Description

It was reported that 2 bd alaris¿ smartsite¿ low sorbing sets broke when attached to their patients during use.The following information was provided by the initial reporter: "in the past two days we have had two add on 0.2 micron filters al10013902 break while attached to patients in our nicu.This is the add-on filter that was recommended to us as a replacement for al 20350e".

• Brand Name: BD ALARIS¿ SMARTSITE¿ LOW SORBING 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: 16191621
• MDR Text Key: 307566477
• Report Number: 9616066-2023-00017
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403233814
• UDI-Public: 10885403233814
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 10013902
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2023
• 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