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

Model Number 11171447

Device Problem Backflow (1064)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/21/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd alaris¿ pump module smartsite¿ infusion set infused chemotherapy medication from the secondary bag into the primary bag of dextro.The following information was provided by the initial reporter: "patient and nurse notice medication was infusing into primary bag of dextro- defect into tubing- medication was changed- infusion was completed.Medication being administrated was chemotherapy.".

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd alaris¿ pump module smartsite¿ infusion set infused chemotherapy medication from the secondary bag into the primary bag of dextro.The following information was provided by the initial reporter: "patient and nurse notice medication was infusing into primary bag of dextro- defect into tubing- medication was changed- infusion was completed.Medication being administrated was chemotherapy.".

Manufacturer Narrative

H6: investigation summary : no product or photo was returned by the customer.It was reported that patient and nurse noticed medication was infusing into the primary bag.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review for model 11171447 lot number 21105051 was performed.The search showed that a total of 14,763 units in 1 lot number was built on 05oct2021.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.H3 other text : see h10.

Event Description

It was reported that the bd alaris¿ pump module smartsite¿ infusion set infused chemotherapy medication from the secondary bag into the primary bag of dextro.The following information was provided by the initial reporter: "patient and nurse notice medication was infusing into primary bag of dextro- defect into tubing- medication was changed- infusion was completed.Medication being administrated was chemotherapy.".

• Brand Name: BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET
• Type of Device: 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: 13499407
• MDR Text Key: 285633538
• Report Number: 9616066-2022-00096
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203021242
• UDI-Public: 37613203021242
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/14/2022

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
• Device Operator: Health Professional
• Device Model Number: 11171447
• Device Catalogue Number: 11171447
• Device Lot Number: 21105051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2022
• Initial Date FDA Received: 02/09/2022
• Supplement Dates Manufacturer Received: 03/14/2022
• Supplement Dates FDA Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1