MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD ALARIS PUMP MODULE SYRINGE ADAPTER SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	10010483
Medical Device Problem Code	Unexpected Color (4055)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris pump module syringe adapter set had discoloration.Report 1 of 3.The following information was provided by the initial reporter with the verbatim: discoloration in the ¿pumping segment¿ of the alaris syringe adaptor set after losec infusion.Purple discoloration of the pumping segment notices after infusion of losec.Noticed with three patients who received losec infusion during the same day.
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: three 10010483 samples were received for investigation; two samples were received without packaging and with residual fluid present in the line, and one sample was received in sealed packaging from lot 22065051.The feedback provided by the customer suggests a purple discolouration of the pumping segment was detected after a losec infusion.As part of the investigation, the customer also returned 40mg omeprazole normon powder.A visual inspection of the returned samples confirmed the customer's experience as the two samples received without packaging had a red discoloured pumping segment, whilst the residual medication in the remainder of the set had resulted in the tubing attaining a dark yellowish colour.The pumping segment was then cut open for a closer inspection; it was not possible to remove the dark red staining to the tubing, suggesting the pumping segment has been stained by the infused medication.The returned 40mg omeprazole normon powder was then dissolved in 100ml of water, and attempts were made to discolour the sample received in sealed packaging, the pumping segment and tubing remained clear throughout.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 22065051 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.A definitive root cause for the customer's experience could not be determined in this instance, however, it appears that the medication used at the time of the event could have contributed to the discolouration of the tubing.Although a definitive root cause could not be determined in this instance, the quality team at the manufacturing site has been informed of this report.
Event or Problem Description
It was reported that bd alaris pump module syringe adapter set had discoloration.Report 1 of 3.The following information was provided by the initial reporter with the verbatim: discoloration in the ¿pumping segment¿ of the alaris syringe adaptor set after losec infusion.Purple discoloration of the pumping segment notices after infusion of losec.Noticed with three patients who received losec infusion during the same day.

• Brand Name: BD ALARIS PUMP MODULE SYRINGE ADAPTER SET
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17686314
• Report Number: 9616066-2023-01840
• Device Sequence Number: 2634452
• Product Code: FPA
• UDI-Device Identifier: 50885403232600
• UDI-Public: (01)50885403232600
• Combination Product (Y/N): N
• Initial Reporter Country: KU
• PMA/510(K) Number: K934095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2023

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: 06/15/2025
• Device Catalogue Number: 10010483
• Device Lot Number: 22065051
• 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: 08/17/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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