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

Catalog Number 2202-0007

Device Problem Obstruction of Flow (2423)

Patient Problem Insufficient Information (4580)

Event Date 07/03/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H3.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 the bd alaris pump module infusion sets are having flow issues.Report 1 of 4.The following was received by the initial reporter: verbatim: generalized complaint that the.2 micron set is having increased occlusion alarms (chop nurses change iv set every 4 days) failure to prime: often can¿t get the lipids through the filter most nurses discard the set and get a new one some nurses are pulling the lipids through the filter with a syringe connected to a port on a trifuse/quadfuse: educated staff that this should not be done.The amount of pressure cannot be controlled and there is risk of damaging the filter.Occlusion alarms: most often occlusion alarms happen when infusion has been stopped to deliver an intermittent medication that is not compatible with the lipids and then restarted.Alarms for occlusion on start-up sometimes: have to hit restart a few times and then it is ok occasionally it alarms occluded while it is running.This typically happens after the 12 hour mark.Cardiac icu/stepdown: frequent challenges failure to prime: throw away set and get a new one occlusion alarms most often occlusion alarms happen when infusion has been stopped to deliver an intermittent medication that is not compatible with the lipids and then restarted.Alarms for occlusion on start-up sometimes: have to hit restart a few times and then it is ok occasionally it alarms occluded while it is running.This typically happens after the infusion has been running 12 hours.Gi: frequent challenges failure to prime: throw away set and get a new one occlusion alarms most often occlusion alarms happen when infusion has been stopped to deliver an intermittent medication that is not compatible with the lipids and then restarted.Alarms for occlusion on start-up sometimes: have to hit restart a few times and then it is ok occasionally it alarms occluded while it is running.This typically happens after the infusion has been running 12 hours.On this unit they often cycle tpn so many patients don¿t receive it for 24 hours.It is over varying times based on each patient.Transplant: frequent challenges failure to prime: throw away set and get a new one: nurses were priming many iv sets upon our arrival.One nurse reported that she just had a failure to prime iv set that she threw away.She removed the set from the trash and you could see that the lipids were only on the inlet side (no packaging available so no lot number) due the long holiday weekend i suspected no one would be able to test the set until the lipids were congealed.So i opened the clamp to see if it would flow (on video) which leads me to believe that some membranes may not be as permeable and if left to sit for awhile the lipids eventually saturate the membrane, allowing the rest of the prime.The set is available to send in to vernon hill (need a label) occlusion alarms most often occlusion alarms happen when infusion has been stopped to deliver an intermittent medication that is not compatible with the lipids and then restarted.Alarms for occlusion on start-up sometimes: have to hit restart a few times and then it is ok occasionally it alarms occluded while it is running.This typically happens after the infusion has been running 12 hours.On this unit they often cycle tpn so many patients don¿t receive it for 24 hours.It is over varying times based on each patient.On the patients that we observed the line change on, there were no occlusion alarms, unrelated to clamp, at the time of set up.On the patients that we observed line change on, i checked in ikp and there were no occlusions on those patients through the night or next day.(none of these patients were receiving a medication that required the infusion to be paused.

Event Description

It was reported the bd alaris pump module infusion sets are having flow issues.Report 1 of 4.The following was received by the initial reporter: verbatim: generalized complaint that the.2 micron set is having increased occlusion alarms (chop nurses change iv set every 4 days) failure to prime: often can¿t get the lipids through the filter most nurses discard the set and get a new one some nurses are pulling the lipids through the filter with a syringe connected to a port on a trifuse/quadfuse: educated staff that this should not be done.The amount of pressure cannot be controlled and there is risk of damaging the filter.Occlusion alarms: most often occlusion alarms happen when infusion has been stopped to deliver an intermittent medication that is not compatible with the lipids and then restarted.Alarms for occlusion on start-up sometimes: have to hit restart a few times and then it is ok occasionally it alarms occluded while it is running.This typically happens after the 12 hour mark.Cardiac icu/stepdown: frequent challenges failure to prime: throw away set and get a new one occlusion alarms most often occlusion alarms happen when infusion has been stopped to deliver an intermittent medication that is not compatible with the lipids and then restarted.Alarms for occlusion on start-up sometimes: have to hit restart a few times and then it is ok occasionally it alarms occluded while it is running.This typically happens after the infusion has been running 12 hours.Gi: frequent challenges failure to prime: throw away set and get a new one occlusion alarms most often occlusion alarms happen when infusion has been stopped to deliver an intermittent medication that is not compatible with the lipids and then restarted.Alarms for occlusion on start-up sometimes: have to hit restart a few times and then it is ok occasionally it alarms occluded while it is running.This typically happens after the infusion has been running 12 hours.On this unit they often cycle tpn so many patients don¿t receive it for 24 hours.It is over varying times based on each patient.Transplant: frequent challenges failure to prime: throw away set and get a new one: nurses were priming many iv sets upon our arrival.One nurse reported that she just had a failure to prime iv set that she threw away.She removed the set from the trash and you could see that the lipids were only on the inlet side (no packaging available so no lot number) due the long holiday weekend i suspected no one would be able to test the set until the lipids were congealed.So i opened the clamp to see if it would flow (on video) which leads me to believe that some membranes may not be as permeable and if left to sit for awhile the lipids eventually saturate the membrane, allowing the rest of the prime.The set is available to send in to vernon hill (need a label) occlusion alarms most often occlusion alarms happen when infusion has been stopped to deliver an intermittent medication that is not compatible with the lipids and then restarted.Alarms for occlusion on start-up sometimes: have to hit restart a few times and then it is ok occasionally it alarms occluded while it is running.This typically happens after the infusion has been running 12 hours.On this unit they often cycle tpn so many patients don¿t receive it for 24 hours.It is over varying times based on each patient.On the patients that we observed the line change on, there were no occlusion alarms, unrelated to clamp, at the time of set up.On the patients that we observed line change on, i checked in ikp and there were no occlusions on those patients through the night or next day.(none of these patients were receiving a medication that required the infusion to be paused.

Manufacturer Narrative

H.6.Investigation summary: no product or photo was returned by the customer.The customer complaint the set was unable to prime past the filter could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed 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.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17421326
• MDR Text Key: 320221464
• Report Number: 9616066-2023-01571
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403274039
• UDI-Public: (01)10885403274039
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2202-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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