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	Air/Gas in Device (4062)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris pump module blood infusion set had air in line the following information was received by the initial reporter with the following verbatim: hope you both are doing well and enjoying some quiet time during the holidays.I wanted to reach out regarding our transition to the bd infusion set with in-line blood filter (2278-0500) and some challenges our staff are experiencing.We have received multiple safety reports that when blood or other blood products are running through the infusion set there are parts throughout the infusion set which has air in the line (some with large areas).Since there is no extra port to withdraw the air from, staff are then needing to stop the line, prime a new tubing set and start again, resulting in lost time and product.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
One photo was taken by the customer that verifies the complaint of air in line.Due to no sample being received further investigation can not be preformed.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.
Event or Problem Description
No additional info.

• 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: 18536843
• Report Number: 9616066-2024-00037
• Device Sequence Number: 6545221
• Product Code: FPA
• UDI-Device Identifier: 50885403223264
• UDI-Public: (01)50885403223264
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2024

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: 2278-0500
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2023
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 04/15/2024
• 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