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

Catalog Number	72215N
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that several bd alaris secondary set experienced air in line.The following information was provided by the initial reporter: rn, stated that yesterday she had a device alarming ail with no air-in-line.Cru reports receiving prepared iv bags/primed iv lines from pharmacy with air in them and have had issues with ail alarms.Clinician reports that the alaris system is ¿very sensitive¿ to ail and that with bbraun it was ¿not much of an issue¿.Clinician also reports that the texium connection on their secondary set ¿holds air¿, and so for secondary infusions they have to wait at the pump when they start the infusion because they will often get ail alarms 30 seconds after starting an infusion.Another clinician states that it is because they cannot prime through the texium that is causing this ail issue.A patient reported that what he liked better about the previous bbraun pumps was that they had a way to get rid of the ail, whereas the alaris pumps stop the infusion and alarms, and then the alarm needs to be addressed by a clinician.Another clinician also states that she has issues with ail and ail moving past the ail sensor.Clinicians report ail issues with certain drugs like etoposide.They report both visible air and nuisance air.Clinicians report that ail sensor is very sensitive.¿ we asked if they have ail issues with texium like the other unit, but they said they would not isolate it to only the texium as it arrives to the clinical unit from pharmacy with bubbles visible.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.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 issues could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 72215n because a lot number was not provided by the customer.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 or Problem Description
It was reported that several bd alaris secondary set experienced air in line.The following information was provided by the initial reporter: rn, stated that yesterday she had a device alarming ail with no air-in-line.Cru reports receiving prepared iv bags/primed iv lines from pharmacy with air in them and have had issues with ail alarms.Clinician reports that the alaris system is ¿very sensitive¿ to ail and that with bbraun it was ¿not much of an issue¿.Clinician also reports that the texium connection on their secondary set ¿holds air¿, and so for secondary infusions they have to wait at the pump when they start the infusion because they will often get ail alarms 30 seconds after starting an infusion.Another clinician states that it is because they cannot prime through the texium that is causing this ail issue.A patient reported that what he liked better about the previous bbraun pumps was that they had a way to get rid of the ail, whereas the alaris pumps stop the infusion and alarms, and then the alarm needs to be addressed by a clinician.Another clinician also states that she has issues with ail and ail moving past the ail sensor.Clinicians report ail issues with certain drugs like etoposide.They report both visible air and nuisance air.Clinicians report that ail sensor is very sensitive.¿ we asked if they have ail issues with texium like the other unit, but they said they would not isolate it to only the texium as it arrives to the clinical unit from pharmacy with bubbles visible.It was reported that several bd alaris secondary set experienced air in line.The following information was provided by the initial reporter: rn, stated that yesterday she had a device alarming ail with no air-in-line.Cru reports receiving prepared iv bags/primed iv lines from pharmacy with air in them and have had issues with ail alarms.Clinician reports that the alaris system is ¿very sensitive¿ to ail and that with bbraun it was ¿not much of an issue¿.Clinician also reports that the texium connection on their secondary set ¿holds air¿, and so for secondary infusions they have to wait at the pump when they start the infusion because they will often get ail alarms 30 seconds after starting an infusion.Another clinician states that it is because they cannot prime through the texium that is causing this ail issue.A patient reported that what he liked better about the previous bbraun pumps was that they had a way to get rid of the ail, whereas the alaris pumps stop the infusion and alarms, and then the alarm needs to be addressed by a clinician.Another clinician also states that she has issues with ail and ail moving past the ail sensor.Clinicians report ail issues with certain drugs like etoposide.They report both visible air and nuisance air.Clinicians report that ail sensor is very sensitive.We asked if they have ail issues with texium like the other unit, but they said they would not isolate it to only the texium as it arrives to the clinical unit from pharmacy with bubbles visible.

• Brand Name: BD ALARIS SECONDARY 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: 14893805
• Report Number: 9616066-2022-00800
• Device Sequence Number: 20403985
• Product Code: FPA
• UDI-Device Identifier: 10885403235467
• UDI-Public: 10885403235467
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K790582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2022

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
• Operator of Device: Other
• Device Catalogue Number: 72215N
• Device Lot Number: UNKNOWN
• 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: 06/03/2022
• Supplement Date Received by Manufacturer: 07/11/2022
• Initial Report FDA Received Date: 07/01/2022
• Supplement Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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