MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. Y MICROBORE EXT W/LUER & 2 SLD CLP; INTRAVASCULAR ADMINISTRATION SET

Model Number	10794983
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	No Information (3190); Insufficient Information (4580)
Date of Event	01/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the y  microbore ext w/luer & 2 sld clp sets distal-end luer lock collar disconnected from the small bore tubing during use.As a result, the tubing connections had to be changed, lumen flushed, epi drip started, and "norepi, tacro, and milrinone" restarted for the patient.The following information was provided by the initial reporter: "patient in critical condition started to show rapid deterioration, appropriate providers at bedside, multiple interventions being done to stabilize patient and upon going to connect epi drip, it was noted that the bi-extension set which multiple infusions (norepi, tacro, milrinone) were infusion had broke off from the lumen.The luer lock piece was still attached however the plastic part was broke and therefore noted that these drugs were not infusing to the patient.It is unknown exactly how long these drugs were not infusing as the area did not seem wet.Tubing connections changes promptly, lumen flushed well with no issues, drugs re-started and epi drip started as well." "luer lock collar at distal end became disconnected from small bore tubing".
Additional Manufacturer Narrative
H6: investigation summary a thorough investigation was performed by our quality team.The samples provided had clear evidence of separation between the optima and the microbore male connection.This verified the complaint of separation.After testing the affected samples, it was apparent that when tightening the microbore tubing past a sealed position will dislodge the spin collar.Customer advocacy and education teams are aware of this issue.When connecting the optima to infusion sets, a soft hand tightening will create a connection that will be impervious to leak once resistance is met.A device history record review for model 10794983 lot number 20095142 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 18sep2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.All samples underwent dimensional analyses and met the manufacturing specifications.The root cause of this failure is disconnect of spin collar due to over tightening.
Event or Problem Description
It was reported that the y  microbore ext w/luer & 2 sld clp sets distal-end luer lock collar disconnected from the small bore tubing during use.As a result, the tubing connections had to be changed, lumen flushed, epi drip started, and "norepi, tacro, and milrinone" restarted for the patient.The following information was provided by the initial reporter: "patient in critical condition started to show rapid deterioration, appropriate providers at bedside, multiple interventions being done to stabilize patient and upon going to connect epi drip, it was noted that the bi-extension set which multiple infusions (norepi, tacro, milrinone) were infusion had broke off from the lumen.The luer lock piece was still attached however the plastic part was broke and therefore noted that these drugs were not infusing to the patient.It is unknown exactly how long these drugs were not infusing as the area did not seem wet.Tubing connections changes promptly, lumen flushed well with no issues, drugs re-started and epi drip started as well." "luer lock collar at distal end became disconnected from small bore tubing".

• Brand Name: Y MICROBORE EXT W/LUER & 2 SLD CLP
• 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 22244 ; MX 22244
• MDR Report Key: 11369946
• Report Number: 9616066-2021-50286
• Device Sequence Number: 13740989
• Product Code: FPA
• UDI-Device Identifier: 50885403234291
• UDI-Public: 50885403234291
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 09/18/2023
• Device Model Number: 10794983
• Device Catalogue Number: 10794983
• Device Lot Number: 20095142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2021
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 06/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention