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

Catalog Number 11532269

Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)

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

Event Date 01/19/2024

Event Type  malfunction  

Event Description

It was reported that bd alaris pump module smartsite low sorbing infusion set separated the following information was received by the initial reporter with the following verbatim: it was reported by customer that the optima injector has disconnected from the component.There will not be any sample for those complaints, lot information is unknown.

Manufacturer Narrative

B3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

No additional information.

Manufacturer Narrative

Pr (b)(4): follow up mdr for correction.Annex a code updated to better reflect event reported by customer.

Event Description

Pr# (b)(4) component separation.

Manufacturer Narrative

No product or photo was returned by the customer.The customer complaint of connection issues could not be verified due to the product not being returned for failure investigation.Bd only received samples for material #11448964; which was covered under pr (b)(4).A device history record review could not be performed on material 11532269 because the lot number is unknown.The root cause of this failure could not be identified without a failure investigation.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE LOW SORBING 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18656020
• MDR Text Key: 334885162
• Report Number: 9616066-2024-00202
• Device Sequence Number: 1
• Product Code: FPA
• 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: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

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 Catalogue Number: 11532269
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2024
• Initial Date FDA Received: 02/06/2024
• Supplement Dates Manufacturer Received: 01/19/2024
• Supplement Dates FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1