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

Catalog Number	10015414
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for additional lot number is as follows: d4.Medical device lot #: 22085998, d4.Medical device expiration date: 29-aug-2025, h4.Device manufacture date: 25-aug-2022.D4.Medical device lot #: 21116351, d4.Medical device expiration date: 29-aug-2025, h4.Device manufacture date: 25-aug-2022.D4.Medical device lot #: 22115749, d4.Medical device expiration date: 29-nov-2025, h4.Device manufacture date: 29-nov-2022.H.6.Investigation summary: a complaint of tubing turning a brown color was received from the customer.No product or photo was returned by the customer.The customer complaint of cosmetic issues - discoloration could not be verified due to the product not being returned for failure investigation.A device history record review for model 10015414 lot number 22085998 was performed.The search showed that a total of (b)(6) units in 1 lot number were built on 29aug2022.A device history record review for model 10015414 lot number 21116351 was performed.The search showed that a total of (b)(6) units in 1 lot number were built on 25nov2021.A device history record review for model 10015414 lot number 22115749 was performed.The search showed that a total of (b)(6) units in 1 lot number were built on 29nov2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that 32 bd alaris pump module blood set experienced foreign matter in fluid pathway.The following information was provided by the initial reporter: tubing has turned a brown color.

• Brand Name: BD ALARIS PUMP MODULE BLOOD 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17061092
• Report Number: 9616066-2023-01089
• Device Sequence Number: 12946363
• Product Code: FPA
• UDI-Device Identifier: 10885403233999
• UDI-Public: (01)10885403233999
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K894842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/18/2023

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 Catalogue Number: 10015414
• Device Lot Number: SEE H10
• 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: 05/12/2023
• Initial Report FDA Received Date: 06/05/2023
• 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