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

Catalog Number 2426-0007

Device Problem Leak/Splash (1354)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 10/27/2023

Event Type  Death  

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 infusion set was damaged and leaking.The following information was received by the initial reporter: situation: (b)(6) 2023, the rn reported, the patients mean arterial pressure dropped to 63 and the iv pump with levophed infusing at 80 mcg/min was beeping with a "check channel" error twice.Al this time, levophed was titrated up.The rn tried to transfer levophed tubing to a different channel and found levophed tubing was leaking.Neo was given per md at the bedside.Pt map rapidly dropped to 48, new tubing restarted, at this lime levophed infusing at 200 mcg/min per md order.The patient became pulseless and cpr was started.The iv tubing was found to have a small hole in ii.During the transfer of the lines, the pt was only supported by neo.Given the brittle and fragile pt, she was unable to tolerate this and coded.She was brought back quickly but was too unstable and coded again.After the 3rd code, the family withdrew care." patient expired on the same day as the event, (b)(6) 2023.Date of event: on (b)(6) 2023.Model#: 2426-0007.Customer response: please share the lot number.Lot number: (10) 23089161, the risk manager investigator was only able to make an ¿educated guess¿ that the lot that we identified is the actual lot of defective tubing leaks.He did not believe that the alaris pump contributed to the line failure.I have attached a photo from his investigation.Any sample or photo available for investigation? picture.If yes, are you able to provide the address of the facility for us to ship the return label? picture.Pertinent history of systemic lupus erythematosus (sle) on immunosuppressive therapy, copd/bronchiectasis on home oxygen, interstitial lung disease of undetermined etiology patient presented at other hospital with viral/bacterial pneumonia, placed on broad-spectrum antibiotics, continue to get worse to a point where she was placed on mechanical ventilation and requiring vasopressor to hold her blood pressure.Transfer requested to baptist for higher level of care and management of acute respiratory distress syndrome, (ards), acute on chronic respiratory failure.Please confirm whether the leakage issue leads to death? level of harm: death.

Manufacturer Narrative

This is a correction as the current mdr is a duplicate to (b)(4) and needs to be canceled.

Event Description

Material#: 2426-0007.Batch number#: 23089161.It was reported by customer that rn reported, the patients mean arterial pressure dropped to 63 and the iv pump with levophed infusing at 80 mcg/min was beeping with a "check channel" error twice.All this time, levophed was titrated up.The rn tried to transfer levophed tubing to a different channel and found levophed tubing was leaking.Neo was given per md at the bedside.Pt map rapidly dropped to 48, new tubing restarted, at this lime levophed infusing at 200 mcg/min per md order.The patient became pulseless and cpr was started.The iv tubing was found to have a small hole in ii.During the transfer of the lines, the pt was only supported by neo.Given the brittle and fragile pt, she was unable to tolerate this and coded.She was brought back quickly but was too unstable and coded again.After the 3rd code, the family withdrew care." patient expired on the same day as the event.Date of event: 27-oct-2023.Model# 2426-0007.Verbatim#: rcc received a complaint via email.Email(s) attached.Situation: (b)(6) 2023, the rn reported, the patients mean arterial pressure dropped to 63 and the iv pump with levophed infusing at 80 mcg/min was beeping with a "check channel" error twice.Al this time, levophed was titrated up.The rn tried to transfer levophed tubing to a different channel and found levophed tubing was leaking.Neo was given per md at the bedside.Pt map rapidly dropped to 48, new tubing restarted, at this lime levophed infusing at 200 mcg/min per md order.The patient became pulseless and cpr was started.The iv tubing was found to have a small hole in ii.During the transfer of the lines, the pt was only supported by neo.Given the brittle and fragile pt, she was unable to tolerate this and coded.She was brought back quickly but was too unstable and coded again.After the 3rd code, the family withdrew care." patient expired on the same day as the event, (b)(6) 2023.Date of event: 27-oct-2023.Model# 2426-0007.Customer response: ¿ please share the lot number.Lot number: (10) 23089161, the risk manager investigator was only able to make an ¿educated guess¿ that the lot that we identified is the actual lot of defective tubing leaks.He did not believe that the alaris pump contributed to the line failure.I have attached a photo from his investigation.¿ any sample or photo available for investigation? - picture.If yes, are you able to provide the address of the facility for us to ship the return label?-picture.¿ please provide any available patient information including age (56)/ date of birth ((b)(6) 1967), sex (female), weight (173.1 lbs.), ethnicity (not hispanic/latino), race(black or african american), other relevant history including preexisting medical conditions.O pertinent history of systemic lupus erythematosus (sle) on immunosuppressive therapy, copd/bronchiectasis on home oxygen, interstitial lung disease of undetermined etiology o patient presented at other hospital with viral/bacterial pneumonia, placed on broad-spectrum antibiotics, continue to get worse to a point where she was placed on mechanical ventilation and requiring vasopressor to hold her blood pressure.Transfer requested to baptist for higher level of care and management of acute respiratory distress syndrome, (ards), acute on chronic respiratory failure.¿ please confirm whether the leakage issue leads to death? level of harm: death.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE 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: 18315141
• MDR Text Key: 330326167
• Report Number: 9616066-2023-02394
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• UDI-Public: (01)10885403227998
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221327
• 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,Followup
• Report Date: 12/27/2023

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: 2426-0007
• Device Lot Number: 23089161
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 12/27/2023
• Supplement Dates FDA Received: 01/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American