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 Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
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 under fusing the following information was received by the initial reporter with the following verbatim: cec rounding on 4 main and rn asked for help with infusing glass tylenol bottle.Rn stated infusion was not running correctly.Cec assessed infusion set up and visually it was correct.Cec asked rn how infusion was initially primed as a secondary medication.Rn unsure as he did not hang or prime medication.Rn obtained new secondary infusion set and changed tubing.Cec provided education on priming with a glass bottle, by first setting glass bottle on counter and spiking bottle, hanging bottle on iv pole and filling the drip chamber 2/3 full before opening up the vent cap.Rn restarted infusion and the secondary tylenol infusion continued to run very slowly.Cec contacted (b)(6), cc (previously visited site with change in secondary tubing).(b)(6) stated that tylenol needs to be vented and to provide education on venting the bottle after spiking for a few seconds, closing the vent cap and then proceeding to fill drip chamber, open vent cap and prime tubing.She also suggested to not backprime glass bottle infusions.This education was provided to (b)(6), rn educator for alaris at upmc (b)(6).

• 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: 18696418
• Report Number: 9616066-2024-00224
• Device Sequence Number: 15536820
• Product Code: FPA
• UDI-Device Identifier: 50885403222618
• UDI-Public: (01)50885403222618
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 02/01/2024

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: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown