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

Catalog Number	2420-0500
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/07/2024
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 damaged the following information was received by the initial reporter with the following: i received four defective alaris tubing sets from our ambulatory infusion center.Their report is the following: one of them had a crack in it and leaked.One was missing the spike.One was damaged at the roller clamp, couldn't move the clamp down.One was damaged up above the fluid chamber, was smashed.
Additional Manufacturer Narrative
The customer reported 4 different issues, and returned four samples.The reports are luer crack and leak, missing spike, roller clamp damage, and smashed above pump.The luer crack sample was signified by a note from the customer and also returned a filter.The set was tested for crack and leakage but no issues were found.The complaint could not be verified.The missing spike was confirmed by the sample, except the spike was completely broken off.The complaint is verified.The roller clamp damage was confirmed with smashed plastic on the top of the roller clamp, and the clamp was stuck in the open position.The complaint is verified.The upper fitment had a smashed blue segment and cracks, causing leakage.It was not reported but it was examined that the drip chamber and spike area was also smashed in and cracked.The complaint is verified.In the 2nd, 3rd, and 4th cases, the reported damage was confirmed.In all 4 cases the manufacturing site conducted a further deep-dive.In all four cases, the root cause was unable to be found.The root cause was not traced to the manufacturing site, and the quality control measures and dhr information did not show any issues.The possible root cause is during transportation, but this cannot be confirmed at this stage in the investigation.Device history record review for model 2420-0500 lot number 24043003 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 02apr2024.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.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.
Event or Problem Description
No additional information was provided.

• Brand Name: BDALARIS 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: 20674719
• Report Number: 9616066-2024-01648
• Device Sequence Number: 12992618
• Product Code: FPA
• UDI-Device Identifier: 07613203012430
• UDI-Public: (01)07613203012430(11)240402(17)270402(10)24043003
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

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: 2420-0500
• Device Lot Number: 24043003
• 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: 10/15/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown