MAUDE Adverse Event Report: BECTON DICKINSON AS LVP 20D DEHP 3SS CV; INTRAVASCULAR ADMINISTRATION SET

Model Number 2426-0500

Device Problems Excess Flow or Over-Infusion (1311); Leak/Splash (1354)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477)

Event Date 01/24/2021

Event Type  Death  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that a as lvp 20d dehp 3ss cv had a defective tubing clamp and flow issues contributing to overinfusion during use.The following was reported by the initial reporter: "it was reported that the slide device was not sufficient to clamp tubing.Verbatim: "i am connecting you with xxxxxx (ccd on this email).He is our contact for the bd alaris 2426-0500 ((b)(4)) product you mentioned a safety issue occurred on.Xxxx has outlined the steps below that will occur when opening a case with customer advocacy." "disclaimer: this was used on a covid positive patient.We have quarantined the set for over a month before sending it to you.Can you describe the reported defect in detail? what happened? what was the cause? who was involved? (b)(6) 2021 patient transferred from (b)(6) to university of (b)(6) health for treatment of acute respiratory failure.He was admitted to the icu.(b)(6) 2021 patient had blood pressures labile all day.The levophed (norepinephrine) 16mg/250 ml was weaned on and off.Patient weight: (b)(6) -- levo started (vtbi: 250ml) @ 0.100 mcg/kg/min @6.3 ml/hr (concentration: 0.064).1751 (b)(6) 2021 the levo was turned off.1900 was shift change.2001 levo was restarted.2127 levo was stopped, removed from the alaris pump.The nurse does not remember if she deployed the slide clamp or the roller clamp.The line was still connected to the patient via internal jugular central line.A bolus of lactated ringers was hung and placed in the pump where the levo had been.The lr was run through a different iv, a peripheral iv.Nursing reports they rely on a mechanism in the slide device that is the portion of the tubing that goes into the pump to activate a clamp.It has been noted that we had an event much like this a few years ago involving propofol and at the time were told that alaris/bd was adding a disclaimer on the tubing to also use the roller clamp.Working root cause: disposable slide device failure (slide device was not sufficient to clamp tubing and human error that the roller clamp or slide clamp were probably not deployed.Contributing factor: novice icu nurse.Nurse involved has only been an rn for 8 months.Staffing on the covid icu was a mix of personnel from various departments.Communication also a factor.Are you able to provide the lot no for the affected item? no.Can you provide the date of event? (b)(6) 2021 at 2127 patient became hypertensive, then extremely hypotensive and low oxygen saturations.(b)(6) 2021 0102 new pump and new tubing and new bag of levophed started on patient.Administered adenosine.0118 start of code; 0153 time of death.Was there any adverse event as a result of the reported defect? if yes, please provide details, in addition to patient identifiers (initials, sex, dob, diagnosis, etc.).(b)(6), male, dob: (b)(6), covid-19/respiratory failure.) are you able to return the affected item? yes, but this may be the second tubing that was hung on the patient at 0102.Unknown.If so, please see the label for the return of the affected item."".

Manufacturer Narrative

H6: investigation summary one sample was received for quality investigation.The customers complaint of tubing defective / damaged could not be verified.The sample submitted was primed and the clamps checked for function.The blue slide clamp was first checked for function while fluid was free to flow.The blue slide clamp functioned as intended.The roller clamp was then checked by allowing fluid to flow through the infusion set and engaging the roller clamp.The clamp worked as intended.The set was then placed in an alaris pump and a simulated infusion conducted.Both clamps were again test and both clamps stopped the fluid flow.Finally, the door of the infusion pump was opened to see if the slide clamp of the pumping segment stopped the fluid flow, and the slide clamp operated as intended.A device history record review could not be performed on model 2426-0500 because a lot number was not provided by the customer.A root cause could not be established because the failure mode could not be replicated.

Event Description

It was reported that a as lvp 20d dehp 3ss cv had a defective tubing clamp and flow issues contributing to overinfusion during use.The following was reported by the initial reporter: "it was reported that the slide device was not sufficient to ¿clamp¿ tubing.Verbatim: "i am connecting you with xxxxxx (cc¿d on this email).He is our contact for the bd alaris 2426-0500 (lawson 1314) product you mentioned a safety issue occurred on.Xxxx has outlined the steps below that will occur when opening a case with customer advocacy." "disclaimer: this was used on a covid positive patient.We have quarantined the set for over a month before sending it to you.Can you describe the reported defect in detail? what happened? what was the cause? who was involved? on (b)(6) 2021 patient transferred from (b)(6) for treatment of acute respiratory failure.He was admitted to the icu.On (b)(6) 2021 patient had blood pressures labile all day.The levophed (norepinephrine) 16mg/250 ml was weaned on and off.Patient weight: 67.6 kg -- levo started (vtbi: 250ml) @ 0.100 mcg/kg/min @6.3 ml/hr (concentration: 0.064).1751 (b)(6) 2021 the levo was turned off.1900 was shift change.2001 levo was restarted.2127 levo was stopped, removed from the alaris pump.The nurse does not remember if she deployed the slide clamp or the roller clamp.The line was still connected to the patient via internal jugular central line.A bolus of lactated ringers was hung and placed in the pump where the levo had been.The lr was run through a different iv, a peripheral iv.Nursing reports they rely on a mechanism in the slide device that is the portion of the tubing that goes into the pump to activate a clamp.It has been noted that we had an event much like this a few years ago involving propofol and at the time were told that alaris/bd was adding a disclaimer on the tubing to also use the roller clamp.Working root cause: disposable slide device failure (slide device was not sufficient to ¿clamp¿ tubing and human error that the roller clamp or slide clamp were probably not deployed.Contributing factor: novice icu nurse.Nurse involved has only been an rn for 8 months.Staffing on the covid icu was a mix of personnel from various departments.Communication also a factor.Are you able to provide the lot no for the affected item? no.Can you provide the date of event? (b)(6) 2021 at 2127 patient became hypertensive, then extremely hypotensive and low oxygen saturations.18/25/21 0102 new pump and new tubing and new bag of levophed started on patient.Administered adenosine.0118 start of code.0153 time of death.Was there any adverse event as a result of the reported defect? if yes, please provide details, in addition to patient identifiers (initials, sex, dob, diagnosis, etc.).(b)(6), male, dob: (b)(6) 1956, covid-19/respiratory failure.) are you able to return the affected item? yes, but this may be the second tubing that was hung on the patient at 0102.Unknown.If so, please see the attached label for the return of the affected item."".

• Brand Name: AS LVP 20D DEHP 3SS CV
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11492429
• MDR Text Key: 239991466
• Report Number: 2243072-2021-00801
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203021006
• UDI-Public: 37613203021006
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2426-0500
• Device Catalogue Number: 2426-0500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 65 YR
• Patient Weight: 68