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

Catalog Number 2420-0500

Device Problem Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Date 03/26/2024

Event Type  Injury  

Manufacturer Narrative

Patient¿s birthday was not provided, 01-jan-xxxx was used based on age of patient the date received by manufacturer has been used for this field.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd alaris pump module smartsite infusion set was over infusing the following information was received by the initial reporter with the following verbatim: we had a medication administration issue that we have not been able to determine what happened.On (b)(6) 2024 at 0830pm, pump 14086036/14089109 was used to administer azithromycin 500mg/250ml over 2 hours.The nurse set the drug as a secondary with a flow rate of 125ml/hr.After 18 minutes, nurse was called back to the room as the patient and mom were reporting the drug had infused already and the iv line had blood backed up into it.The nurse tried multiple time to flush the blood back.Tubing and setup were verified by a second nurse immediately after it was reported.Camera review shows correct drug, iv bag size and secondary tubing were used.Pump has been removed from service.Patient experienced immediate gi discomfort from the rapid administration of azithromycin and needed a x1 ondansetron administered.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE INFUSION 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: 19072129
• MDR Text Key: 339725996
• Report Number: 9616066-2024-00548
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203012430
• UDI-Public: (01)07613203012430
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2420-0500
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• 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
• Patient Age: 7 YR
• Patient Sex: Male
• Patient Weight: 78 KG