MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D DEHP 3SS CV; INTRAVASCULAR ADMINISTRATION SET

Model Number 2426-0500

Device Problems Complete Blockage (1094); Leak/Splash (1354)

Patient Problem Cardiac Arrest (1762)

Event Date 12/24/2020

Event Type  Death  

Manufacturer Narrative

Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 20073374, medical device expiration date: 2023-07-20, device manufacture date: 2020-07-16.Medical device lot #: unknown, medical device expiration date: unknown, device manufacture date: unknown.(b)(4).Investigation summary: a complaint of flow issues with a set was received from the customer.No product or photo was returned by the customer.A device history record review for model 2426-0500, lot number 20073374 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 20jul2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Investigation conclusion: the customer complaint of flow issues could not be verified due to the product not being returned for failure investigation.The customer complaint of clamp issues could not be verified due to the product not being returned for failure investigation.The customer complaint of leakage could not be verified due to the product not being returned for failure investigation.Root cause description: due to no sample being received, an investigation could not be performed and a root cause could not be determined.Rationale: this incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the as lvp 20d dehp 3ss cv had flow issues with the tubing leaking propofol when not connected to the patient, even though the roller clamp was closed.The following information was provided by the initial reporter: "admitted on (b)(6) 2020 for covid pneumonia, hyperkalemia, respiratory failure, dm2, heart failure w/ preserved ef, and encephalopathy.Pulse ox ~ 88%.Placed on non-rebreather, then required intubation on (b)(6) for sats in the 70%.She was started on decadron.Creat cl was 40 so remdesivir was held.Convalescent plasma given.On 12/24 @ 0159 o2 sat 75 ¿ 80 on vent, maximum vent settings, high peep, fio2 100.Fluid overload ¿ given lasix.Patient was prone.At 0737, in preparation for changing the propofol infusion, a bottle was primed and attached to the main ns iv tubing below the pump and clamped.The primary rn told another rn hat the propofol may run out and to keep a listen for the pump to beep.The new bottle was ready to be placed on the pump when this happened.Bp ~169/67 until 0841 when it dropped to 32/21.O2sat was 75%.The charge nurse noted the patient's hr to be 64 (had been 75 ¿ 85).The respiratory therapist was in the room.The charge nurse asked the rt to check for a pulse.Patient had no pulse: pulseless electrical activity (pea) arrest.Acls done with alternating return of pulse and pea until 1012 when the patient expired.Primary rn made a statement that the whole propofol bottle was empty at the beginning of the code.The roller clamp was noted to be open.Unsure if the roller clamp status is a product defect or human error.Patient also had dopamine, epinephrine, levophed, and vasopressin drips hanging.During interviews, staff said the tubing for propofol had leaked on the floor on at least two prior occasions when a new bottle was set up for change out.These times the tubing was not connected to the patient.(b)(6) 2021 update on 2nd event: the defect was the end of the tubing was slowly dripping propofol when not connected to the patient, but the roller clamp was closed.".

Manufacturer Narrative

Correction: h1: type of reportable events: death.

Event Description

It was reported that the as lvp 20d dehp 3ss cv had flow issues with the tubing leaking propofol when not connected to the patient, even though the roller clamp was closed.The following information was provided by the initial reporter: "admitted on (b)(6) 2020 for covid pneumonia, hyperkalemia, respiratory failure, dm2, heart failure w/ preserved ef, and encephalopathy.Pulse ox ~ 88%.Placed on non-rebreather, then required intubation on (b)(6) for sats in the 70%.She was started on decadron.Creat cl was 40 so remdesivir was held.Convalescent plasma given.On (b)(6) @ 0159 o2 sat 75 ¿ 80 on vent, maximum vent settings, high peep, fio2 100.Fluid overload ¿ given lasix.Patient was prone.At 0737, in preparation for changing the propofol infusion, a bottle was primed and attached to the main ns iv tubing below the pump and clamped.The primary rn told another rn hat the propofol may run out and to keep a listen for the pump to beep.The new bottle was ready to be placed on the pump when this happened.Bp ~169/67 until 0841 when it dropped to 32/21.O2sat was (b)(4).The charge nurse noted the patient's hr to be 64 (had been 75 ¿ 85).The respiratory therapist was in the room.The charge nurse asked the rt to check for a pulse.Patient had no pulse: pulseless electrical activity (pea) arrest.Acls done with alternating return of pulse and pea until 1012 when the patient expired.Primary rn made a statement that the whole propofol bottle was empty at the beginning of the code.The roller clamp was noted to be open.Unsure if the roller clamp status is a product defect or human error.Patient also had dopamine, epinephrine, levophed, and vasopressin drips hanging.During interviews, staff said the tubing for propofol had leaked on the floor on at least two prior occasions when a new bottle was set up for change out.These times the tubing was not connected to the patient.01/04/2021 update on 2nd event: the defect was the end of the tubing was slowly dripping propofol when not connected to the patient, but the roller clamp was closed.".

• Brand Name: AS LVP 20D DEHP 3SS CV
• 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 22244 ; MX 22244
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244 ; MX 22244
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11206300
• MDR Text Key: 229595295
• Report Number: 9616066-2021-50085
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203021006
• UDI-Public: 37613203021006
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/20/2023
• Device Model Number: 2426-0500
• Device Catalogue Number: 2426-0500
• Device Lot Number: 20073374
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2022
• 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
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 117 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White