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

Catalog Number	20129E
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
Type of Reportable Event	Malfunction
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
It was reported that bd alaris extension set was occluded the following information was received by the initial reporter with the following : reported issue per customer: pt pump alarming pt side occluded, fixed pressure reading after filter was replaced.
Event or Problem Description
No additional information was provided.Materials: 20129e batch#: unknown.It was reported by the customer that reported issue per customer: pt pump alarming pt side occluded, fixed pressure reading after filter was replaced.Verbatim: rcc received a complaint via email.Email(s) attached.Injuries or adverse event: no medline reference #: (b)(4).Item: 20129e quantity affected: 1 ea po #: 451693550.Are any samples available for return? yes.Reported issue per customer: pt pump alarming pt side occluded, fixed pressure reading after filter was replaced.Customer disposition request: replacement.
Additional Manufacturer Narrative
It was reported by the customer that the pump was alarming indicating an occlusion.One sample of material number 20129e was submitted for quality investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was attached to a bd primary set and primed with 85% glycerin / 15% water.An infusion run was started at a rate of 1 ml/hr for 24 hrs.There was no observation of pump interaction issues.The customer complaint was unable to be replicated.Although the issue was unable to be replicated and the root cause is unknown, bd is looking at opportunities to improve the filter function to alleviate this failure in the future.See the attached ¿filtering out the facts: recommendations to optimize performance of in-line filters for parenteral nutrition and intravenous fat emulsion infusions (ivfe)¿ for additional information regarding the use of ivfe with in-line filter administration sets.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.

• Brand Name: BD ALARIS EXTENSION 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: 18891899
• Report Number: 9616066-2024-00421
• Device Sequence Number: 6130930
• Product Code: FPA
• UDI-Device Identifier: 50885403234901
• UDI-Public: (01)50885403234901
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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): 04/05/2024

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: 20129E
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2024
• Supplement Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 04/30/2024
• 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