MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD ALARIS PUMP MODULE BLOOD INFUSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	2278-0500
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris pump module blood infusion set was under infusing the following information was received by the initial reporter with the following verbatim: it was reported by customer that the blood tubing spike stuck in blood bag at time of flush, resulting in patient not receiving final 30 ml flush and losing 30 ml prbc.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint of connection issues 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 2278-0500 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
Pr# (b)(4) concurrent flow/simultaneous flow (underinfusion).The customer reported the blood spike stuck in the bag, and returned one used set of material 2278-0500, lot unknown.Upon initial visual examination, the set had no defects or abnormalities.The set was tested by connecting to an iv bag in the lab, but no issues were observed.There was no flow achieved in the set, as the dried blood has clogged the set.The spike was able to create a seal in the bag, and it was also able to be removed.The spike dimensions were verified to be within specification using the microscope.A device history record review could not be performed on material 2278-0500 because the lot number is unknown.The supplier for the spike component was contacted and they were able to confirm that the manufacturing process does not have a root cause for the issue.The root cause 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.

• Brand Name: BD ALARIS PUMP MODULE BLOOD INFUSION 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: 19806991
• Report Number: 9616066-2024-01019
• Device Sequence Number: 12700095
• Product Code: FPA
• UDI-Device Identifier: 10885403223266
• UDI-Public: (01)10885403223266
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

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: 2278-0500
• 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: 06/25/2024
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 09/25/2025
• 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