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

Catalog Number	2260-0500
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris pump module low sorbing set was over infusing the following information was received by the initial reporter with the verbatim: "the bag was labeled as having 250mls in it, the pump was programmed to infuse the ordered volume over 24 hours.In 3 hours, the pump alarmed and the entire volume of the bag (250ml) had infused.The pump was correctly programmed and verified via 3 rns.".
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
The customer reported that the infusion completed too quickly.Two samples were received for quality investigation.One sample of infusion set 2260-0500 was submitted with an unknown secondary infusion set.The infusion sets were visually examined and no damages or abnormalities were visually identified.The infusion sets were then primed and a simulated infusion was conducted at a flow rate of 125 ml/hr.There were no issues of occlusions or backflow found during testing.In order to replicate the failure reported, all the infusion set clamps were left open.Fluid from one of the infusion bags would flow into the other bag giving the appearance that the entire infusion bag was empty before its programmed infusion rate.The customer complaint of flow issues - accuracy was not confirmed.Based on the investigation findings, and the failure not being replicated under normal use, the root cause is considered to be a misuse of the infusion set that caused for the infusion to have appeared to have been conducted faster than expected.A device history record review could not be performed because the lot number is unknown.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No further information was provided.

• Brand Name: BD ALARIS PUMP MODULE LOW SORBING SET
• Common Device Name: 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: 19927509
• Report Number: 9616066-2024-01100
• Device Sequence Number: 18201389
• Product Code: FPA
• UDI-Device Identifier: 07613203012591
• UDI-Public: (01)07613203012591
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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
• Operator of Device: Other
• Device Catalogue Number: 2260-0500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown