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

Catalog Number	2477-0000
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
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 pump module smartsite blood set was leaking the following information was received by the initial reporter with the verbatim: on (b)(6) 2023.A patient in our medical day clinic was receiving a unit of red blood cells and when the nurse was doing their 15 minutes post start of transfusion assessment noted that the tubing just above the nonvented drip chamber was leaking blood at 1105h.The transfusion was stopped and the unit of red blood cells with tubing was sent back to our transfusion medicine department.I have reached out to the our transfusion medicine department to see if the tubing is still available to send back to bd for investigation and will let you if it is.
Additional Manufacturer Narrative
It was reported that the tubing was leaking above the drip chamber.One sample model 2477-0000 was returned for investigation.The set was attached to an iv bag filled with normal saline and allowed to flow.No leaks were observed.The customer complaint that there was leakage was not confirmed.The root cause could not be determined because the issue could not be replicated.A device history record review could not be performed because a lot number was not provided by the customer.
Event or Problem Description
No additional info.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE BLOOD 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: 18607395
• Report Number: 9616066-2024-00119
• Device Sequence Number: 15711695
• Product Code: FPA
• UDI-Device Identifier: 37613203011328
• UDI-Public: (01)37613203011328
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K894842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

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: 2477-0000
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 03/20/2024
• 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 Age: 72 YR
• Patient Sex: Male