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	02/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.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 verbatim reported issue: lipid filter occluded, switched to new one and alarm for occlusion stopped.
Event or Problem Description
No further information was provided.Materials: 20129e batch#: 23119256 it was reported by the customer that we have received a quality complaint on product sold to our customer.Please contact the customer and cc distributedquality@medline.Com and lselk@medline.Com on any future communication.Verbatim: rcc received a complaint via email.Email(s) attached.We have received a quality complaint on product sold to our customer.Please contact the customer and cc distributedquality@medline.Com and lselk@medline.Com on any future communication.Injuries or adverse event: yes item: 20129e quantity affected: (b)(4) ea serial/lot number: (b)(6).Po : 4516935508 are any samples available for return? yes reported issue: lipid filter occluded, switched to new one and alarm for occlusion stopped.Customer disposition request: replacement additional information received on 20-feb-2024 morning, i am following up from a quality complaint on product sold to our customer.Please respond accordingly with the rma number, if necessary, and the disposition of the concern.Please contact the customer and cc me on any future communication laura selk good morning, the event date was 02/03/24 and i will be shipping out the sample today.While the event occurred while in use with a patient no serious injury/harm was done., (b)(6).
Additional Manufacturer Narrative
The customer reported that the filter occluded.One sample model 20129e was returned for 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 1ml/hr for 24 hrs.There was no observation of fluid blockage.The customer complaint was unable to be replicated.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.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.A device history record review for model 20129e lot number 23119256 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 22nov2023.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.
Event or Problem Description
No additional information was provided.Materials: 20129e batch#: 23119256.It was reported by the customer that we have received a quality complaint on product sold to our customer.Please contact the customer and cc distributedquality@medline.Com and lselk@medline.Com on any future communication.Verbatim: rcc received a complaint via email.Email(s) attached.We have received a quality complaint on product sold to our customer.Please contact the customer and cc distributedquality@medline.Com and lselk@medline.Com on any future communication.Injuries or adverse event: yes.Item: 20129e quantity affected: 1 ea serial/lot number: (b)(6).Po : (b)(6).Are any samples available for return? yes.Reported issue: lipid filter occluded, switched to new one and alarm for occlusion stopped.Customer disposition request: replacement.Additional information received on 20-feb-2024.Morning, i am following up from a quality complaint on product sold to our customer.Please respond accordingly with the rma number, if necessary, and the disposition of the concern.Please contact the customer and cc me on any future communication.(b)(6).Good morning, the event date was 02/03/24 and i will be shipping out the sample today.While the event occurred while in use with a patient no serious injury/harm was done., (b)(6).
Additional Manufacturer Narrative
The customer reported that the filter occluded.One sample model 20129e was returned for 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 1ml/hr for 24 hrs.There was no observation of fluid blockage.The customer complaint was unable to be replicated.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.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.A device history record review for model 20129e lot number 23119256 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 22nov2023.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 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: 18862335
• Report Number: 9616066-2024-00364
• Device Sequence Number: 3306655
• 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,Followup
• Report Date (Section B): 05/10/2024

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: 23119256
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/05/2024; 05/10/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 04/30/2024; 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown