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

Model Number 2420-0007

Device Problems Leak/Splash (1354); Defective Device (2588)

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

Event Date 03/07/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that during use with an unspecified amount of bd alaris¿ pump module smartsite¿ infusion set a device component was discovered to be damaged.There was no patient impact.The following information was provided by the initial reporter: it was reported by the customer that product was damage no leakage was reported.

Manufacturer Narrative

The following fields were updated due to additional information: device available for eval yes, returned to manufacturer on: 11-aug-2023 investigation summary one sample was submitted for quality investigation.The customer complaint of component damage - leak was verified by inspection.The inspection started with a visual inspection of the infusion set.There was no indication of damage during the initial visual inspection.The infusion set was then primed to check for leakage and a leak was found at the bottom of the pumping segment in the silicone tubing.Further inspection of the silicone tubing under magnification, indicates that there is a tear in the silicone tubing.No further issues were identified during inspection.A device history record review for model 2420-0007 lot number 22075048 was performed.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 the damage seen in this complaint is a misloading of the infusion set into the alaris pump.Based on the information provided by the customer, the leak from the pumping segment was not noticed until the infusion set was placed into the alaris pump and not noticed during priming of the infusion set.If the infusion set is not loaded properly, there is a possibility for the soft silicone tubing to tear when the door of the alaris pump is closed.H3 other text : see h10.

Event Description

It was reported that during use with an unspecified amount of bd alaris¿ pump module smartsite¿ infusion set a device component was discovered to be damage with leakage.There was no patient impact.The following information was provided by the initial reporter: it was reported by the customer that product was damage with leakage.

Manufacturer Narrative

Correction: describe event or problem: it was reported that during use with an unspecified amount of bd alaris¿ pump module smartsite¿ infusion set a device component was discovered to be damage with leakage.There was no patient impact.The following information was provided by the initial reporter: it was reported by the customer that product was damage with leakage.Imdrf annex a grid: (b)(4).

Event Description

It was reported that during use with an unspecified amount of bd alaris¿ pump module smartsite¿ infusion set a device component was discovered to be damage with leakage.There was no patient impact.The following information was provided by the initial reporter: it was reported by the customer that product was damage with leakage.

• 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 ; 8448235433
• MDR Report Key: 17148950
• MDR Text Key: 317967382
• Report Number: 9616066-2023-01203
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: (01)07613203021012
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K944320
• 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,Followup
• Report Date: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: 22075048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2023
• Initial Date FDA Received: 06/16/2023
• Supplement Dates Manufacturer Received: 07/28/2023; 08/16/2023
• Supplement Dates FDA Received: 08/06/2023; 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2022
• 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