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

Catalog Number	2278-0500
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd bd alaris pump module blood infusion set was leaking the following information was received by the initial reporter with the following verbatim it was reported by the customer that iv pump channel noted blood throughout.¿ parent noticed blood dripping on floor, notified rn.¿ rn investigated and inside iv pump channel noted blood throughout.¿ source of damage in tubing unable to be identified.¿ rn notified blood bank who advised to clamp the port spiked with tubing.¿ advised that bag of blood could still be infused with new tubing in other available port.¿ new tubing hung.¿ transfusion proceeded without incident.
Event or Problem Description
No further information was provided.
Additional Manufacturer Narrative
It was reported by the customer that iv pump channel noted blood throughout.One sample of item number 2278-0500 was submitted for quality evaluation.Visual inspection was performed and there were no damages or abnormalities identified in the sample.The sample was then primed and a simulated infusion was conducted at a flow rate of 125ml/hr.Leakage was not identified in the sample.The sample was then tested by pressurizing it with 10 psi and placing the sample under water to identify any leaks.There were no leaks identified during testing.The customer complaint of leakage was not verified.A root cause for the reported failure was not established because the failure could not be replicated.A device history record review for model 2278-0500 lot number 24066739 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 24jun2024.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 INFUSION 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: 20538485
• Report Number: 9616066-2024-01542
• Device Sequence Number: 20914095
• Product Code: FPA
• UDI-Device Identifier: 10885403223266
• UDI-Public: (01)10885403223266(11)240624(17)270624(10)24066739
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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: 2278-0500
• Device Lot Number: 24066739
• 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: 09/26/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown