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

Catalog Number UNKNOWN

Device Problem Backflow (1064)

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

Event Date 02/29/2024

Event Type  malfunction  

Event Description

It was reported that unspecified bd infusion set malfunctioned the following information was received by the initial reporter with the following verbatim: ¿this morning a nurse brought me in to a room to look at her potassium ivpb set up.All tubing is connected correctly, unclamped, set up as a secondary, etc.Height difference between primary and secondary is appropriate (i took a pic in case we need).The potassium was programmed to run at 50 ml/hr[should be a total runtime of 1 hr].After 20 minutes the potassium bag was empty but the primary fluid bag had gotten completely full.I had a similar instance reported to me yesterday where a zosyn ran back in to the vial, instead of in to the patient.The tubing has a backflow valve that is supposed to keep the fluid running one way but this seems to be malfunctioning.It seems very odd that i have gotten two reports of malfunctioning secondaries in the past two days.I'm wondering if we can reach out to our alaris rep and see if they have had other reports of this.And maybe also check the mso forums?¿ we are currently just asking questions as the most likely culprit seems to be the tubing.

Manufacturer Narrative

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

• Brand Name: UNSPECIFIED BD 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: 18975850
• MDR Text Key: 339050874
• Report Number: 9616066-2024-00467
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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: 03/04/2024

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• 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