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

Catalog Number 10015861A

Device Problem Backflow (1064)

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

Event Date 12/18/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd alaris pump module smartsite low sorbing infusion set check valve malfunctioned.The following information was received by the initial reporter with the verbatim: in this case, we were used the bd low sorbing secondary set with attached texium (ref 70001b-07t) and the bd pump infusion set low sorb tubing (ref 10015861a) that was running chemotherapy into a patient with an ivad.There was also a texium attached at the bottom of this setup, directly to the ivad.When we set up this infusion, we ¿dry spike¿ the secondary bag with the secondary tubing clamped, and then back prime from the primary bag once the secondary bag is spiked.When the secondary infusion beeps that it is complete, there is usually a little bit of overfill remaining in the secondary bag.Our practice here is to manually use gravity to assist the bag to empty by lifting it higher to allow the remaining volume to fully infuse.When the volume from the secondary tubing is completely emptied down to where it reaches the primary tubing, we clamp it and let the primary flush the line for an additional 20ml.In this case, no matter how high the nurse lifted the secondary bag, he could not get the remaining volume to drain and it continued to pull from the primary (despite volume in the secondary bag being well above the primary bag).He said that as he attempted to get the secondary bag to finish infusing, eventually the primary bag began to back fill into the secondary and air was pulled into the pump channel and he could not complete the remaining chemotherapy volume.It seems like this happens every so often.Chemotherapy is the only drug that we are extremely specific about getting every ml of the secondary bag infused, so these are the only incidents this is reported.Do they have any idea the mechanism that causes this to occur? any troubleshooting suggestions or any solutions to help the bag empty? i am not sure if this is a fluke when this happens, a tubing malfunction, or set up error that we are unaware of.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE LOW SORBING 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18489648
• MDR Text Key: 333002715
• Report Number: 9616066-2023-02510
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403232624
• UDI-Public: (01)50885403232624
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/26/2023

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: Other
• Device Catalogue Number: 10015861A
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1