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

Catalog Number	41173E
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris gravity set had flow issues.The following information was received by the initial reporter with the following: it was reported by customer that when the gravity tubing was being primed with normal saline, the bedside they noted an unusually slow drip rate, which did not improve with completely opening the roller clamp.(there needs to be free flow of fluid through this tubing when stem cells are infusing to avoid clumping of cells or other adverse effects.) this tubing was discarded and replaced with a new set of gravity tubing, which dripped appropriately.Product information: xx smartsite gravity set, needle-free valve (vented/nonvented) ref: 41173e (alaris products) lot: h37041173e1d (both sets of gravity tubing used were from this lot.) during the stem cell infusion, one side of the spike adapter (a y-shaped piece of tubing that is used to spike the small fluid bags & the stem cell bags) had one side that was not clamping.The bedside they had to use a hemostat to clamp that side when it was not supposed to be dripping.Spike adapter - two spikes to one spike port with 20cm scd tubing and pinch clamps ref: 2s-p20, lot: v23644 the stem cells were able to be infused.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint of flow issues accuracy 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: 41173e because the lot number is incorrect.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.

• Brand Name: BD ALARIS GRAVITY 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: 22598004
• Report Number: 9616066-2025-02124
• Device Sequence Number: 4084410
• Product Code: FPA
• UDI-Device Identifier: 07613203020893
• UDI-Public: (01)07613203020893
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2025

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: 41173E
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/24/2025
• 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