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

Catalog Number UNKNOWN

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Insufficient Information (4580)

Event Date 01/11/2024

Event Type  malfunction  

Manufacturer Narrative

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 unspecified bd infusion set was over infusing the following information was received by the initial reporter with the following verbatim: it was reported that on 03 january 2024 at 2008, a 20meq potassium chloride (kcl) infusion was programmed with interoperability and had infused in 15 minutes although it was intended to infuse in one hour.The routine kcl was hung as a piggyback with an intended rate of 50mlhr.The nurse called the pharmacy and they changed the large volume pump module (lvp), the pc unit, and the secondary tubing.However it was mentioned that the event happened again.The nurse then changed the lvp and pc unit again and clamped the secondary tubing half way to slow down the infusion.The first event happened during the night shift.It was then reported that the patients potassium was high after the event at 6.8.The day shift nurse mentioned that the potassium was still infusing fast, and that they had continued to clamp the secondary halfway to slow the infusion down.They did not change the tubing.The potassium came back high, and they initially thought that it was not correct which lead to the labs being redrawn and it was found that the potassium came back as 6.3.The providers were notified and 80mg of lasix was given to correct it.

• 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: 18660175
• MDR Text Key: 334773538
• Report Number: 9616066-2024-00209
• 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: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• 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: 01/18/2024
• 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