MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. ALS SET DC 20DP 3SS CKVLV LOW SRB DEHP F; INTRAVASCULAR ADMINISTRATION SET

Model Number	24600-0007
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 as lvp 20d 1.2m was blocked/occluded during use and the nurse could not pull fluid through with a syringe.The following information was provided by the initial reporter: "bd alaris pump tubing with inline 1.2 micron filter clogged with intralipid fat emulsion.Lipids had been running for approximately 16 hours.After removal, rn attempted to pull fluid through with a syringe and was unable to despite maximal force.24 hours later, this submitter was able to attach a stopcock and pull fluid through the filter with no issues, although did feel to be higher than expected resistance.".
Additional Manufacturer Narrative
H.6.Investigation: customer reported leakage along the line, and returned the affected sample.The sample was submerged in water and pressurized to find the leak, and then the red tape was placed near the leak.Visual inspection under the microscope found that the leak came from a bubbled out, stressed area of tubing.The root cause for this damage is unknown.Some options are a kink, inadvertent sharp object, or inadvertent excessive heat.A device history record review for model 24600-0007 lot number 20056922 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of leakage with lot #20056922 regarding item #24600-0007 h3 other text : see h.10.
Event or Problem Description
It was reported that the als set dc 20dp 3ss ckvlv low srb dehp f experienced leakage.The following information was provided by the initial reporter: material no: 2426-0007, batch no: 20056922.When priming the line with normal saline- rn notice there is leakage along the line.

• Brand Name: ALS SET DC 20DP 3SS CKVLV LOW SRB DEHP F
• 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: 10935718
• Report Number: 9616066-2020-20502
• Device Sequence Number: 3240937
• Product Code: FPA
• UDI-Device Identifier: 50885403241978
• UDI-Public: 50885403241978
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2020

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: 05/26/2023
• Device Model Number: 24600-0007
• Device Catalogue Number: 24600-0007
• Device Lot Number: 20056922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 01/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 DA