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

Catalog Number 2426-0500

Device Problem Infusion or Flow Problem (2964)

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

Event Date 03/25/2024

Event Type  malfunction  

Manufacturer Narrative

B3.The date received by manufacturer has been used for this field.H.3.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: it was reported that the device had potassium bag scanned in.The potassium bag was piggybacked with a 100 ml bag of ns on channel.The potassium was programmed at 100ml/hour per the order.This was y-sited into tubing with d5lr running at 150 ml/hr on channel.After 15 minutes of transfusing, the nurse noticed that approximately half the bag was infused.Then the nurse slowed the infusion down to 50 ml/hr to compensate for the perceived incorrect infusion rate.At 09:50, second bag of 10 meq of iv kcl is started at 100 ml/hr as a secondary infusion.The same tubing and bag of 100 ml of ns was utilized.By time 10:00, the staff have noticed the infusion was running too fast (88 gtts per minute, approximately 264 ml/hr), then the infusion has been decreased to 50 ml/hr again (64 gtts per minute, approximately 192ml/hr).At time 10:05, the staff have interpreted the infusion rate based off gtts.All infusions were paused and clamps on the patient side were clamped.With all pumps paused, the potassium piggyback tubing was still dripping.At this point, the staff noticed that the 100 ml bag of ns appeared overfilled with fluid.There was patient involvement, but no patient harm.

• 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: 19129170
• MDR Text Key: 341368592
• Report Number: 9616066-2024-00591
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203020992
• UDI-Public: (01)07613203020992
• 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: 04/01/2024

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: 2426-0500
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/17/2024
• 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