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

Catalog Number 2420-0007

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Date 02/29/2024

Event Type  malfunction  

Event Description

It was reported that bd alaris pump module smartsite infusion set malfunctioned the following information was received by the initial reporter with the following verbatim: hello, there was another bd alaris iv check valve failure here yesterday q: please describe the incident a: cipro 200mg in 100ml was ordered, pharmacy dispensed 400mg/200ml premixed bag.I programed pump to run 200mg/100ml.Pt already had ns@ 100ml/hr running as primary fluid.Mrp ordered pt to be saline locked at 1445.I went to d/c primary fluids and noticed the secondary bag was completely emptied and the primary bag only had about 400 ml missing.Being it was hung around 8am it should have had 600ml infused accounting for the pause to infuse 100ml of iv abx from the secondary.Mrp was notified immediately and then mrp went on to notify pt and pts family.Q: was there any harm or impact to the patient? please be specific.A: no.Potential harm being pt got too little or to much abx but impossible to tell.Q: how was treatment completed for the patient? a: fluids were stopped at 1445 as per mrp order and today was the last ordered day for the iv abx cipro a once daily medication.Q: what medications were being infused when the incident occurred? a: ciprofloxacin (cipro iv) 2mg/1ml 200 ml inj.Q: what was the name of the medication/fluid that over/under infused? a: ciprofloxacin (cipro iv) 2mg/1ml 200 ml inj.Q: was this a "stat" medication or a routine order? a: routine.Q: what was the intended volume to be infused (vtbi)? a: 100ml secondary and ns 100ml/hr primary hours of 0800-1445.Q: what was the total bag/bottle volume and concentration? a: 400mg/200ml dispensed pump programed to infuse 200mg/100ml.Q: are there any other infusions currently running at the time of the event? a: ns@100ml/hr primary which would pause during secondary infusion.Q: if so, please list the fluids/medication (name and rate of infusion): a: ns@100ml/hr primary which would pause during secondary infusion.Q: how was the medication/fluid programmed into the pump? a: manually, using guardrails drug library.Q: how was treatment completed for the patient? a: fluids were stopped at 1445 as per mrp order and today was the last ordered day for the iv abx cipro a once daily medication.

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 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: 18975983
• MDR Text Key: 339144394
• Report Number: 9616066-2024-00469
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: (01)07613203021012
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K221327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2420-0007
• Device Lot Number: 23125355
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1