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

Model Number	10013361T
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd alaris pump module smartsite texium infusion set there was a blockage.There was no report of patient impact.The following information was provided by the initial reporter: they stated that their practice for administration of an ivp via this texium set has not changed during this trial with optima being used at the distal access port of the set for an ivp.Prior to optima they used a texium bonded ivp syringe for administration.Xxx reached out to the primary rn for the exact details.This is what they stated, ¿i noticed the drip rate had slowed down and when i started pushing the drug, the drip had completely stopped and the drug would starting back up the y-site towards the pump.I didn¿t do the pinch line method for this because of how slow the carrier fluid was flowing.Once the line was slightly clear, i would then pinch the line and check for blood return.With the second syringe, i noticed the pressure to push the drug would increase when the syringe was close to being halfway empty (like maybe 10mls left).At one point, i pushed the drug a little too hard and the patient reported feeling pressure at his port site.The patient¿s port site was assessed and drug/fluid was not noted but they did report the sensation of feeling something wet.With the last two syringes, we decided to run the carrier fluid through the pump at 250mls/hr and would pause the pump and check blood return using that method.¿ their concern was that the optima components was stopping the infusion flow during the ivp.I provided education regarding using the alaris iv set for ivp administration and that they should be clamping the line during the push procedure so that drug moves down the line and not up the line which can cause issues with the pump segment if the line is not clamped.Also, the drug they were pushing was very viscous.I am not sure whether or not they fully engaged the texium component to the patient's access port.
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd alaris pump module smartsite texium infusion set there was a blockage.There was no report of patient impact.The following information was provided by the initial reporter: they stated that their practice for administration of an ivp via this texium set has not changed during this trial with optima being used at the distal access port of the set for an ivp.Prior to optima they used a texium bonded ivp syringe for administration.Reached out to the primary rn for the exact details.This is what they stated, ¿i noticed the drip rate had slowed down and when i started pushing the drug, the drip had completely stopped and the drug would starting back up the y-site towards the pump.I didn¿t do the pinch line method for this because of how slow the carrier fluid was flowing.Once the line was slightly clear, i would then pinch the line and check for blood return.With the second syringe, i noticed the pressure to push the drug would increase when the syringe was close to being halfway empty (like maybe 10mls left).At one point, i pushed the drug a little too hard and the patient reported feeling pressure at his port site.The patient¿s port site was assessed and drug/fluid was not noted but they did report the sensation of feeling something wet.With the last two syringes, we decided to run the carrier fluid through the pump at 250mls/hr and would pause the pump and check blood return using that method.¿ their concern was that the optima components was stopping the infusion flow during the ivp.I provided education regarding using the alaris iv set for ivp administration and that they should be clamping the line during the push procedure so that drug moves down the line and not up the line which can cause issues with the pump segment if the line is not clamped.Also, the drug they were pushing was very viscous.I am not sure whether or not they fully engaged the texium component to the patient's access port.
Additional Manufacturer Narrative
H6: investigation summary : no product or photo was returned by the customer.The customer complaint that there was fluid blockage could not be verified due to the product not being returned for failure investigation.A device history record review for model 10013361t lot number 23035235 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.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE TEXIUM 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17322391
• Report Number: 9616066-2023-01449
• Device Sequence Number: 12134325
• Product Code: FPA
• UDI-Device Identifier: 50885403223202
• UDI-Public: (01)50885403223202
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2023

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: 03/11/2026
• Device Model Number: 10013361T
• Device Catalogue Number: 10013361T
• Device Lot Number: 23035235
• 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: 06/22/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2023
• 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