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

Catalog Number	72213N
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported issue with iron infusion, and returned one primary set of material 2420-0007, and one secondary set of material 72213n.The sets were both returned with pr 10878290, for the primary set.This complaint was opened for the secondary set.Visual examination was conducted on both sets that were submitted and there was no indication of damages or abnormalities.The primary set was then primed with water, and the secondary set was primed with water with blue color dye.The sets were then connected and a simulated infusion was conducted at rate of 125 ml/hr.Immediately as the simulated infusion was started it could be seen that the back check valve on the primary set was allowing for the fluid from the secondary to back flow into the primary bag.The customer complaint of flow issues - backflow was confirmed.Since the primary set's back check failed, there is no issue with the secondary set.A device history record review could not be performed on material 72213n because the lot number is unknown.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.
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 had flow issues the following information was received by the initial reporter with the following.I am trying to get a hold of a picture that was taken but the nurse who took the picture is off today.Basically, an iron product was hanging on a secondary tubing set and saline in the primary line.The pump correctly pulled the iron product but some of the product back primed into the primary saline bag.When the rn entered the room there was visible iron in the bottom of the primary saline bag.I am unsure if it is a primary tubing issue or a secondary tubing issue.Hopefully that helps!.

• 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: 20592112
• Report Number: 9616066-2024-01583
• Device Sequence Number: 6567380
• Product Code: FPA
• UDI-Device Identifier: 07613203010078
• UDI-Public: (01)07613203010078
• 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
• Report Date (Section B): 12/24/2024

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: 72213N
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 12/24/2024
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 12/24/2024
• 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