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

Catalog Number	2452-0007
Medical Device Problem Codes	Leak/Splash (1354); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd alaris pump module smartsite infusion set was bulging the following information was received by the initial reporter with the following verbatim: rcc received a complaint via email.Email(s) attached.Contrast attached to lower y site (of ns access line) near patient's hand.Pump channel alarmed during ct scan, and then rubberized part of tubing audibly "popped", spraying ns into the air.Once scan was complete, it was noted that there was leakage all over the floor.Patient was assessed first and was deemed stable.It was noted that the source of the leak was the tubing inside the pump channel.The floor was sticky despite the access being ns, and the ct techs stated that the contrast is sticky.The contrast likely was partially pumped back up into the iv pump.According to the tech, there was no negative impact to the scanned image.
Additional Manufacturer Narrative
It was reported by customer that rubberized part of tubing audibly "popped", spraying ns into the air.Four photos were submitted from the customer for quality evaluation.Review of the photos submitted by the customer indicate that the photos do not match the material number reported.Additionally, the photos were compared to the engineering assembly drawings of the reported product, and the photos did not match the assembly drawings.The customer complaint of bulge/balloon in the silicone pumping segment could not be confirmed.A root cause analysis was not performed because the failure could not be confirmed with the information and photos provided.A device history record review could not be performed because the lot number is unknown.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information was provided.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE 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: 19785249
• Report Number: 9616066-2024-00998
• Device Sequence Number: 8278636
• Product Code: FPA
• UDI-Device Identifier: 10885403219870
• UDI-Public: (01)10885403219870
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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
• Operator of Device: Other
• Device Catalogue Number: 2452-0007
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 07/19/2024
• Supplement Report FDA Received Date: 10/15/2024
• 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