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

Model Number 2426-0007

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 09/23/2022

Event Type  malfunction  

Manufacturer Narrative

The customer reported separation from the upper fitment of the silicon pumping segment, and returned pictures of the incident.There is no physical sample, and thus a root cause cannot be found.The upper fitment is a press fit, and has no solvent.The press fit is caused by the little blue ring retainer, which if not attached, signifies a manufacturing error.The root cause in the case there is a ring retainer is the user - we urge our customers to load the set into the pump correctly.However, the root cause cannot be verified in this case as the picture shown helps to find the failure location, but is a representative sample.Device history record review for model 2426-0007 lot number 22059209 was performed.The search showed that a total of 28,803 units in 1 lot number was built on (b)(6) 2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

Event Description

It was reported while using bd alaris pump module smartsite infusion set separation and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: on (b)(6) 2022, we had a safety event report on the bd alaris pump infusion sets with backcheck valve and 3 smartsites y site.Unfortunately, the defective item was not retained by the reporter of the event.However, the reporter did share a representative picture of the product and in the picture pointed out the area where the leak/split occurred.Bd 219: report date: (b)(6) 2022 event date: (b)(6) 2022 item number: bd alaris pump infusion set back check valve 3 smartsite y sites/ bd alaris¿ lvp 20d 3ss cv; mfr: 2426-0007; lot number: (10)22059209; item retained in defect depot?: no; picture: representative picture provided with leak/split site pointed out; no harm was reported to the patient.Location: ambulatory treatment center ¿ west houston event details: ¿i circle primed the nivolumab manually (without using the pump machine/module)in the med prep area.Before hanging the bag, i noted that my gloves were wet.I immediately looked at the nivolumab bag, and discovered that the 3 smartsite bd alaris has split into two parts; separated/ has a tear between the hard plastic part and the soft plastic part(which you load first when you put the alaris in the module).No further spill occurred on the floors.¿.

• 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: 15794598
• MDR Text Key: 307992734
• Report Number: 9616066-2022-01720
• 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: 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
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: 22059209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2022
• 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