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

Catalog Number	MS3500-15
Medical Device Problem Codes	Backflow (1064); Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2024
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 secondary set was occluded the following information was received by the initial reporter with the following verbatim: 2.7.24- nurse in cvc went in as pump was beeping completed, secondary line was clamped, writer unclamped secondary line and reprogrammed pump to infuse secondary medication.50 minutes later pump beeping for completion a second time- secondary medication did not infuse, fluid in drip chamber noted.Equipment/supplies involved- bd pump infusion set back check valve ref (b)(4).Bd secondary set (vented/nonvented) m53500-15.Mini-bag unasyn;250 ml ns bag: lot #: v23l01k, brand: baxter;bd secondary set: lot #:(10)23103174 brand: bd;alaris pump (#1-206) & channel (#2-191) alaris brain and channels along with tubing and product failure forms available in colleen bell¿s office.No checks of the alaris brain or channels by biomed at this time as we were awaiting bd site visit for next steps.
Event or Problem Description
Customer reply: please share the correct lot number for the alaris tubing? iv tubing involved listed above but product not saved so no lot number available.· describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.Delay in timely delivery of antibiotic.Unable to ascertain whether effects on patient treatment.
Additional Manufacturer Narrative
Dhr only.No product or photo was returned by the customer.The customer complaint of secondary set failed to infuse even when unclamped - occlusion in set - could not be verified due to the product not being returned for failure investigation.Device history record review for model ms3500-15 lot number 23103174 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 31oct2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.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 SECONDARY 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: 18849635
• Report Number: 9616066-2024-00367
• Device Sequence Number: 7486104
• Product Code: FPA
• UDI-Device Identifier: 50885403222618
• UDI-Public: (01)50885403222618
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K790582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2024

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: MS3500-15
• Device Lot Number: 23103174
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2024
• Supplement Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown