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

Catalog Number 2441-0007

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/20/2024

Event Type  malfunction  

Event Description

It was reported that bd alaris pump module smartsite infusion burette set was damaged the following information was received by the initial reporter with the following verbatim.Factual description of the event: found wet spot on iv infusion pump.Wiped area off and saw that there was dripping coming from iv bag.Inspected bag and found no visible tears/leaking.Then noticed that top small valve on buretrol set was open and small drops of water were forming.Contacted pharmacy for new bag of fluid and reprimed uvc line sterilly to baby.Charge nurse manager aware, buretrol saved and given to (b)(6), rn, (b)(6) manager.

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE INFUSION BURETTE SET
• Type of Device: 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: 19113528
• MDR Text Key: 341015183
• Report Number: 9616066-2024-00567
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403235047
• UDI-Public: (01)10885403235047
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2024

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
• Device Operator: Other
• Device Catalogue Number: 2441-0007
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1