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

Catalog Number 10942011

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

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

Event Date 04/10/2023

Event Type  malfunction  

Event Description

It was reported that the bd alaris¿ pump module infusion set leaked from a hole in the tubing during the chemo infusion.The following information was provided by the initial reporter: "issue: the primary tubing that chemo was running through was leaking.The day shift nurse mentioned cleaning up some liquid off the floor but couldn't figure out where it came from.She said she traced the lines and didn't notice anything wrong with the tubing.However, the leak was coming from the part of the tubing that sits inside the chamber.Only a small amount was cleaned up off the floor.Chemo np was notified and said the chemo didn't need to be redosed.The line was flushed was ns and new tubing was set up to finish the chemo.Additional information: there is a hole in the tubing.It's not a loose connection.".

Manufacturer Narrative

A.2.Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.E.4.Fda notified?: the initial reporter also notified the fda via (b)(4).H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 07-jun-2023 h6: investigation summary the customer reported leaking from the chamber on chemo tubing and returned one used sample.The sample verified the report as there was a hole in the upper fitment part of the silicon.Pumping segment leaks such as this are considered user error, and we urge the customer to carefully load the sets into the pump.Device history record review for model 10942011 lot number 23025288 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

Event Description

It was reported that the bd alaris¿ pump module infusion set leaked from a hole in the tubing during the chemo infusion.The following information was provided by the initial reporter: "issue: the primary tubing that chemo was running through was leaking.The day shift nurse mentioned cleaning up some liquid off the floor but couldn't figure out where it came from.She said she traced the lines and didn't notice anything wrong with the tubing.However, the leak was coming from the part of the tubing that sits inside the chamber.Only a small amount was cleaned up off the floor.Chemo np was notified and said the chemo didn't need to be redosed.The line was flushed was ns and new tubing was set up to finish the chemo.Additional information: there is a hole in the tubing.It's not a loose connection.".

• Brand Name: BD ALARIS¿ PUMP MODULE 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 ; 8448235433
• MDR Report Key: 16908556
• MDR Text Key: 315296934
• Report Number: 9616066-2023-00869
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403232404
• UDI-Public: 10885403232404
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K931173
• 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: 07/25/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 10942011
• Device Lot Number: 23025288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2023
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: 07/25/2023
• Supplement Dates FDA Received: 08/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2023
• 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
• Patient Age: 6 YR
• Patient Sex: Male