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

Catalog Number	42521E
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that bd alaris smartsite gravity set was occluded.The following information was received by the initial reporter with the verbatim: material no.: 42521e lot no.: (10)23069291 customer stated that the tip of the drip chamber is occluded.This has happened on 2 tubings of the same lot.
Additional Manufacturer Narrative
It was reported by customer that the tip of the drip chamber is occluded.Four samples of material number 42521e were received for quality evaluation.A visual inspection of all the samples was conducted to determine if there were any visible defects or damages to the construction of each set.There were no visual issues detected.The samples were then attempted to be primed with water.Three of the samples submitted did not allow for fluid to move past the drip chamber.The fourth sample allowed fluid to flow freely with no issues.A simulated infusion was conducted on the fourth sample to determine if flow was restricted.The infusions set flowed fluid as intended.With three of the samples submitted, the customer complaint of flow issues - fluid blockage was verified.The investigation was forwarded to the manufacturing location.After review of the manufacturing process, the root cause for the issue was determined to be excess solvent used during the assembly process due to issues with the solvent dispenser.The assembly process has been updated and additional assembly fixtures, along with replacing the medical solvent dispenser, was implemented to avoid the issue in future production.A device history record review for model 42521e lot number 23069291 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 22jun2023.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 further information was provided.Material#: 42521e, batch#: (10)23069291.It was reported by customer that the tip of the drip chamber is occluded.This has happened on 2 tubings of the same lot.Verbatim: material no.: 42521e, lot no.: (10)23069291.Customer stated that the tip of the drip chamber is occluded.This has happened on 2 tubings of the same lot.Rcc received complaint via phone.Pir attached.Additional info received on 02-nov-2023.1.What is the date of the event? a.Multiple occurrences.2.Is the sample or photographs available for evaluation? if yes, please provide shipping address for sending a return label from us rcc for investigation purposes.A.I have the samples of the tubing available.(b)(6).3.Was the product received in this condition? a.Yes, the product was occluded coming out of the package.4.If not, what was the product being used for when the reported issue was observed? a.The tubing was used to hydrate a patient before or after a surgical procedure.5.Please confirm whether or not there was any patient impact.A.No.6.When did the reported issue happen? before use, during use, after use? a.The first incident was reported to me on (b)(6) 2023 at 0756.Several more incidents have been reported since the first occurrence.Once the fluid bag was spiked, the fluids would not descend into the tubing with the roller clamp in the open position.7.What was the medication being administered? a.Normal saline.

• Brand Name: BD ALARIS SMARTSITE GRAVITY 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: 18117141
• Report Number: 9616066-2023-02177
• Device Sequence Number: 6988457
• Product Code: FPA
• UDI-Device Identifier: 50885403274259
• UDI-Public: (01)50885403274259
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• 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): 01/22/2024

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 Expiration Date: 06/22/2026
• Device Catalogue Number: 42521E
• Device Lot Number: 23069291
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 11/11/2023
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown