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

Catalog Number	10012645
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that that the bd alaris¿ pump module smartsite¿ infusion set tubing was defective detached from the drip chamber during use.The following information was provided by the initial reporter: "did you keep the defective tubing? no, tubing was contaminated with blood that could not be contained due to nature of tubing failure." "the ¿lid¿ portion of the drip chamber detached from the actual chamber.".
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device evaluated by mfr: a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary: no product or photo was returned by the customer.The customer complaint of tubing defective/damaged could not be verified due to the product not being returned for failure investigation.A device history record review for model 10012645 lot number 20095843 was performed.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.
Event or Problem Description
It was reported that that the bd alaris¿ pump module smartsite¿ infusion set tubing was defective detached from the drip chamber during use.The following information was provided by the initial reporter: "did you keep the defective tubing? no, tubing was contaminated with blood that could not be contained due to nature of tubing failure." "the ¿lid¿ portion of the drip chamber detached from the actual chamber.".
Additional Manufacturer Narrative
Correction: after further evaluation of the complaint, it has been determined that the mdr 9616066-2023-00046 is a duplicate of 9616066-2023-00037 this supplemental is to cancel mdr 9616066-2023-00046.
Event or Problem Description
It was reported that that the bd alaris¿ pump module smartsite¿ infusion set tubing was defective detached from the drip chamber during use.The following information was provided by the initial reporter: "did you keep the defective tubing? no, tubing was contaminated with blood that could not be contained due to nature of tubing failure.".

• Brand Name: BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16230061
• Report Number: 9616066-2023-00046
• Device Sequence Number: 5500387
• Product Code: FPA
• UDI-Device Identifier: 10885403233753
• UDI-Public: 10885403233753
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/14/2023

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: 09/08/2023
• Device Catalogue Number: 10012645
• Device Lot Number: 20095843
• 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: 01/03/2023
• Supplement Date Received by Manufacturer: 03/14/2023; 03/14/2023
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 03/13/2023; 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2020
• 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