MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS LVP SS BAG 20D LOW SORB SS 0.2M; INTRAVASCULAR ADMINISTRATION SET

Model Number	2465-0007
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported when using the bd alaris lvp ss bag 20d low sorb ss 0.2m, the user experienced an occluded product.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: we have a question about filter tubing with erbitux.Have you heard any problems with the lines failing "pump occluded" this is the second time this has happened.
Event or Problem Description
It was reported when using the bd alaris lvp ss bag 20d low sorb ss 0.2m, the user experienced an occluded product.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: we have a question about filter tubing with erbitux.Have you heard any problems with the lines failing "pump occluded" this is the second time this has happened.
Additional Manufacturer Narrative
H.6.Investigation: no product or photo was returned by the customer.The customer complaint that the line is occluded could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

• Brand Name: BD ALARIS LVP SS BAG 20D LOW SORB SS 0.2M
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13418627
• Report Number: 9616066-2022-00053
• Device Sequence Number: 17360993
• Product Code: FPA
• UDI-Device Identifier: 50885403221949
• UDI-Public: 50885403221949
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• 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): 02/15/2022

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: 2465-0007
• Device Catalogue Number: 2465-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2022
• Supplement Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown