MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP SS BAG 20D TEX; INTRAVASCULAR ADMINISTRATION SET

Model Number	22000-B007T
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: the photo provided by customer exhibits clear lack of tension ring used to keep tubing on the silicone pump segment placed in infusion pump.This will lead to leakage and separation verifying the customer's complaint.A device history record review could not be performed because a lot number was not provided by the customer.Investigation conclusion: this incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.Root cause description: the root cause remains unknown without a sample available to investigate.It is to be known that proper loading technique be stressed when loading infusion pumps as failure to follow protocol has lead to this failure before.
Event or Problem Description
It was reported that as lvp ss bag 20d tex leaked.The following information was provided by the initial reporter: material #: 22000-b007t.Batch/ lot #: unknown.It was reported that the tubing was leaking from the section that sits in the pump.Verbatim: "i followed up with the charge nurse for the leaky gemcitabine from monday.It was a tubing leak from the section that sits in the pump.".

• Brand Name: AS LVP SS BAG 20D TEX
• 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: 11269066
• Report Number: 9616066-2021-50149
• Device Sequence Number: 3256485
• Product Code: FPA
• UDI-Device Identifier: 50885403245020
• UDI-Public: 50885403245020
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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
• Report Date (Section B): 01/19/2021

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 Model Number: 22000-B007T
• Device Catalogue Number: 22000-B007T
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1