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

Catalog Number	2260-0500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint of component damage - leak could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on material 2260-0500 because the lot number is unknown.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.
Event or Problem Description
It was reported that bd alaris pump infusion set was broken.The following information was received by the initial reporter with the following verbatim it was reported by the customer that the part below the spike broke off on his alaris pump.
Additional Manufacturer Narrative
One sample was received for quality evaluation.Visual inspection of the sample indicates that the tubing separated at the lower pumping segment fitting to the silicone tubing.Further examination under magnification shows that the securement collar was missing from the set, however, an indention in the silicone tubing can be seen on the tubing.The customer complaint of component damage was not verified, but separation was identified.The investigation was forwarded to manufacturing for root cause analysis.After evaluation of the sample and the information provided by the customer stating that the infusion set broke while in the pump, it is assumed that there was no issue identified during priming.The issue was identified after the infusion set was inserted into the pump.Additionally, an indention of the securement ring can be seen on the silicone tubing, and therefore a manufacturing defect could not be concluded.A root cause for the issue could not be determined.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.
Additional Manufacturer Narrative
Correction to investigation summary: one sample was received for quality evaluation.Visual inspection of the sample indicates that the tubing separated at the lower pumping segment fitting to the silicone tubing.Further examination under magnification shows that the securement collar was missing from the set, however, an indention in the silicone tubing can be seen on the tubing.The customer complaint of component damage was not verified, but separation was identified.The investigation was forwarded to manufacturing for root cause analysis.After evaluation of the sample and the information provided by the customer stating that the infusion set broke while in the pump, it is assumed that there was no issue identified during priming.The issue was identified after the infusion set was inserted into the pump.Additionally, an indention of the securement ring can be seen on the silicone tubing, and therefore a manufacturing defect could not be concluded.A root cause for the issue could not be determined.A device history record review could not be performed on material 2260-0500 because the lot number is unknown.

• Brand Name: BD ALARIS PUMP INFUSION SET
• Common Device Name: 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: 22041223
• Report Number: 9616066-2025-01273
• Device Sequence Number: 8880052
• Product Code: FPA
• UDI-Device Identifier: 07613203012591
• UDI-Public: (01)07613203012591
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2026

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
• Operator of Device: Other
• Device Catalogue Number: 2260-0500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 01/14/2026; 02/11/2026
• Initial Report FDA Received Date: 05/17/2025
• Supplement Report FDA Received Date: 01/15/2026; 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown