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 Backflow (1064); Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 10/16/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: unknown, medical device expiration date: unknown, device manufacture date: unknown.Medical device lot #: 20073103, medical device expiration date: 2023-07-08, device manufacture date: 2020-06-30.(b)(4).Investigation summary: no product or photo was returned by the customer.The customer complaint of tubing would not prime, of blood backing up causing leakage, of leakage from the primary tubing during the paclitaxel infusion when the "equashield" connection was loose and at end of taxol infusion, and of fluid was leaking out of tubing closest to the port most proximal to the patient 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 2426-0500 because a lot number was not provided by the customer.A device history record review for model 2426-0500, lot number 9309923 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 08jul2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Investigation conclusion: this incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: due to no sample being received, an investigation could not be performed and a root cause could not be determined.

Event Description

It was reported that as lvp 20d dehp 3ss cv had leakage and blood backing up.The following information was provided by the initial reporter: event 1: material no: 2426-0500, batch no: unknown.It was reported that the tubing would not prime causing a slight delay with time sensitive medication.Event 2: material no: 2426-0500, batch no: 20073103.It was reported that the infusion set had a breach/ hole.It was reported that iv fluid and blood backed up and poured onto the floor.Event 3: material no: 2426-0500, batch no: unknown.It was reported that the patient noticed leakage from the primary tubing during the paclitaxel infusion when the "equashield" connection was loose and at end of taxol infusion.Event 4: material no: 2426-0500, batch no: unknown.It was reported that fluid was leaking out of tubing closest to the port most proximal to the patient.Please see below concerns regarding our primary tubing.Ref 2426-0500 patient requiring tpa administration, when i went to prime the tubing, i was able to fill the chamber but tubing would not prime, all clamps were open, second rn check- would not prime, tubing changed and primed ok- but this issue caused a slight delay with time sensitive medication.Alaris iv pump infusion set (iv tubing) had a breach/hole, pouring iv fluid and backed up patient blood onto the floor.Iv fluid was infusing to gravity.Stat stores notified of lot number (10)20073103.Pt was having first paclitaxel infusion.Pt called.Nurse/kate went to infusion room 3.Pt reported his left arm t shirt was damp.Paclitaxel infusion was finishing soon.Infusion was stopped.Noticed equashield connection was loose.Checked all connections and make sure tight.Dried tubing.Has good blood return from iv.Pt's left arm was dry already.Asked pt to take off his t shirt, put in a pt belonging bag.Asked pt to wash it separately at home later.Cleaned left arm with soap & water, then dried out.Restarted paclitaxel.Pt moved arm, pt noticed small leakage from primary tubing again at end of taxol infusion.Took down primary saline and taxol tubing, changed to new primary saline line, started carboplatin infusion.Infusion was fine after.Got a scrub top from pharmacist.Pt put on scrub top after infusion.4.Patient was receiving ivig through primary tubing when she noticed it was leaking onto her sweater.Nothing was disconnected or dislodged but fluid was leaking out of tubing closest to port most proximal to the patient.

• 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: 10824693
• MDR Text Key: 217995234
• Report Number: 9616066-2020-20297
• 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
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• 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: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2020
• 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 Outcome(s): Other