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

Model Number	11426964
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 a "red spray" substance was found in the as lvp 20d low sorb tubing chamber.The following information was provided by the initial reporter: "hello, we have noticed some red spray substance in the chamber of the tubing today.".
Additional Manufacturer Narrative
H6: investigation summary a complaint on foreign matter found in the drip chamber was received from the customer.Three sample were returned for investigation.Through visual inspection, the complaint was verified.Red specks were seen embedded throughout the entire drip chamber on all three samples.A device history record review for model 11426964 lot number 20085877 was performed.The search showed that a total of 11,523 units in 1 lot number was built on 08aug2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A root cause could not be determined at this time, but the supplier has initiated an investigation to further test the sample.H3 other text : see h10.
Event or Problem Description
It was reported that a "red spray" substance was found in the as lvp 20d low sorb tubing chamber.The following information was provided by the initial reporter: "hello, we have noticed some red spray substance in the chamber of the tubing today.".

• Brand Name: AS LVP 20D LOW SORB
• 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: 11313768
• Report Number: 9616066-2021-50211
• Device Sequence Number: 715600
• Product Code: FPA
• UDI-Device Identifier: 50885403232365
• UDI-Public: 50885403232365
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• 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): 03/03/2021

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 Expiration Date: 08/08/2023
• Device Model Number: 11426964
• Device Catalogue Number: 11426964
• Device Lot Number: 20085877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1