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	Leak/Splash (1354); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
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 leaking.The following information was received by the initial reporter with the following verbatim.It was reported by customer that they are experiencing breaking, separation and cracking of the iv tubing when taking the iv tubing out of the packages.In addition, when nurses begin to prime their iv fluids through the tubing, they are also having issues.Additionally, that the nurses are experiencing leaking from the iv tubing after an infusion has been hung and infusing for a few hours.
Event or Problem Description
Material # ms3500-15, batch # unknown.It was reported by customer that they are experiencing breaking, separation and cracking of the iv tubing when taking the iv tubing out of the packages.In addition, when nurses begin to prime their iv fluids through the tubing, they are also having issues.Additionally, that the nurses are experiencing leaking from the iv tubing after an infusion has been hung and infusing for a few hours.Verbatim: rcc received a complaint via email.Email(s) attached.Nurses have been experiencing breaking, separation and cracking of the iv tubing when taking the iv tubing out of the packages.In addition, when nurses begin to prime their iv fluids through the tubing, they are also having issues.Additionally, keith stated that nurses are experiencing leaking from the iv tubing after an infusion has been hung and infusing for a few hours.Keith stated this most commonly is occurring with bd alaris pump infusion sets that are used for primary infusions in the icu.(ref #(b)(4).Nurses have also experienced issues with bd secondary set (ref#(b)(4).No patient harm.No additional details provided.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint of separation other component - no 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 ms3500-15 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.
Additional Manufacturer Narrative
The customer reported tubing is separating, and returned one sample of material ms3500-15, lot unknown.The customer included a note for "ceftriaxone set to infuse as secondary, never infused at all".Upon initial visual examination, the set had no defects or abnormalities.The set, along with the returned 2420-0007 primary set, were infused at 125 ml/hr for 1 hour to check for occlusion.No issues were observed, and without a replicated failure, the complaint could not be verified.The root cause for the occlusion could not be found without a verified failure.A device history record review could not be performed on material ms3500-15 because the lot number is unknown.
Event or Problem Description
No additional information.

• 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: 21139738
• Report Number: 9616066-2024-02249
• Device Sequence Number: 20572273
• Product Code: FPA
• UDI-Device Identifier: 50885403222618
• UDI-Public: (01)50885403222618
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• 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,Followup
• Report Date (Section B): 03/31/2025

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: 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: 12/19/2024
• Supplement Date Received by Manufacturer: 01/23/2025; 03/04/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 01/23/2025; 04/01/2025
• 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