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

Catalog Number	10015414
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris pump module blood set was backflowing the following information was received by the initial reporter with the following verbatim: 4/24/2024: 566867: product saved.Patient administered rbcs through blood tubing and blood back-primed into the other tube/spike and dripped on to the floor.Lot # (10)24015446.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
It was reported by the customer that the patient administered rbcs through blood tubing and blood back-primed into the other tube/spike and dripped on to the floor.One sample of material number 10015414 was received.Visual inspection was conducted on the infusion set to determine if any damages or abnormalities could be identified.The were no damages or abnormalities.The infusion set was then primed with water and a simulated infusion was conducted.Backflow was only recreated when the infusion set was used incorrectly.If the inlet tubing lines are not clamped off correctly, using the blue slide clamps, one of the infusion bags will empty into other infusion bag.The infusion set worked properly when using the slide clamps correctly.The customer complaint of blood backs up / blood not completely expelled was not verified by investigation of the sample submitted.A root cause was not determined because the reported issue with the infusion set could not be replicated.The bd clinical team has been made aware of the issue and will contact the customer to determine if additional training or instructional material is needed for the use of the product.A device history record review for model 10015414 lot number 24015446 was performed.The search showed that a total of (b)(6) units in 1 lot number was built on 19jan2024.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD ALARIS PUMP MODULE BLOOD 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: 19324168
• Report Number: 9616066-2024-00762
• Device Sequence Number: 19478433
• Product Code: FPA
• UDI-Device Identifier: 10885403233999
• UDI-Public: (01)10885403233999
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 06/27/2024

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: 10015414
• Device Lot Number: 24015446
• 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: 04/25/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown