MAUDE Adverse Event Report: CAREFUSION AS LVP 20D LOW SORB 2SS 0.2M CV; INTRAVASCULAR ADMINISTRATION SET

Model Number 11532269

Device Problems Backflow (1064); Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 08/17/2020

Event Type  Injury  

Manufacturer Narrative

Weight: (b)(6) kilograms.Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that as lvp 20d low sorb 2ss 0.2m cv tubing came apart which caused blood backflow and loss.The following information was provided by the initial reporter: material no.: 11532269, batch no: 20065136.It was reported the tubing came apart resulting in blood backing up as well as blood loss.In response to the below questions about the patients that were involved in the alaris tubing that became disconnected i will give you what i know came from to very low birth weight infants, where the situation caused about 5 to 8mls of blood to be backed up and lost.For each infant.Baby #1- female, birth weight (b)(6), picc line 1.9 fr in place.Baby #2 male, birth weight (b)(6) , picc line 1.9 fr in place both of these situations occurred when the tubing came apart where the line goes directly into the 0.2 micron filter.This caused the blood to back up into the tubing.The main problem beside the blood loss for these infants is the fact that the picc line can clot off since it is so small in diameter.Because then we would have to put in another picc subjecting the infant to another central line insertion.There were several other infants that this happened to as well.Not all of the tubing was saved for me.We took out that lot number form our pyxis machine and used a different lot number.So far i have not seen this happen again.

Event Description

It was reported that as lvp 20d low sorb 2ss 0.2m cv tubing came apart which caused blood backflow and loss.The following information was provided by the initial reporter: material no.: 11532269 batch no: 20065136.It was reported the tubing came apart resulting in blood backing up as well as blood loss.In response to the below questions about the patients that were involved in the alaris tubing that became disconnected i will give you what i know came from to very low birth weight infants, where the situation caused about 5 to 8mls of blood to be backed up and lost.For each infant.(b)(6)- female, birth weight 600 grams (1 lb, 4 ounces), picc line 1.9 fr in place.(b)(6) male, birth weight 480 grams (1 lb) , picc line 1.9 fr in place.Both of these situations occurred when the tubing came apart where the line goes directly into the 0.2 micron filter.This caused the blood to back up into the tubing.The main problem beside the blood loss for these infants is the fact that the picc line can clot off since it is so small in diameter.Because then we would have to put in another picc subjecting the infant to another central line insertion.There were several other infants that this happened to as well.Not all of the tubing was saved for me.We took out that lot number form our pyxis machine and used a different lot number.So far i have not seen this happen again.

Manufacturer Narrative

The following fields were updated due to additional information: d.10 device available for eval yes, d.10 returned to manufacturer on: 08/21/2020.Investigation conclusion: it was reported that the tubing separated and leaked.The event set model 11532269 lot 20065136 was not received for evaluation.A total of (b)(4) new and sealed sets model 115532269 lot 20065136 were received for multiple failure modes and all sets were tested for the specific failure mode reported within each individual (b)(4).The sets were visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.No anomalies or issues were observed with the sets during initial visual inspection.Functional testing was performed by attaching the sets to a 1000ml iv bag filled with blue dye water and priming via gravity.18g cannulas were attached to the primary setsâ¿¿ male luers and the sets primed via gravity with no separations or any leak issues.One 10ml lab syringe of water were attached to each of the setsâ¿¿ smartsites.The syringe plunger was gently depressed and no issues were observed.The sets were then loaded into a lab pump module for a primary infusion and programmed for a rate of 120ml/hr and vtbi of 30ml.The infusions completed with correct amount of fluid infused and with no backflow issues.The sets were pressure tested while submerged underwater (per dir #10000360033 â¿¿ iv disposable leak test method).Air pressure was incrementally increased from 5 psi to 30 psi.No leaks or any issues were observed with any of the returned sets.Additional testing was performed by tugging on the engagements and tubing with normal force.No separations were observed.Equipment used (measurement and testing performed on 19sep2020) air pressure regulator with pressure gauge, eq00151, calibration due date: 07nov2020 8015 alaris pcu 1.5, eq08330, calibration due date: 04aug2021.8015 alaris pcu 1.5, eq10291, calibration due date: 20mar2021.8100 alaris system lvp, eq08327, calibration due date: 16nov2020.8100 alaris system lvp, eq103048, calibration due date: 12aug2021.8100 alaris system lvp, eq08470, calibration due date: 05jun2021.8100 alaris system lvp, eq08475, calibration due date: 12aug20201.8100 alaris system lvp, eq08328, calibration due date: 05jun20201.8100 alaris system lvp, eq102428, calibration due date: 13aug2021.A device history record for model 11532269 with lot number 20065136 was performed.The search showed that a total of (b)(4) units were built in 1 lot on 01jun2020.The search showed that there were no quality notifications for the failure mode reported by the customer.The customer's report that the tubing separated and leaked was not confirmed.The root cause of the customerâ¿¿s experience was not identified as no separations or leaks were observed during functional and pressure testing.H3 other text : see h10.

• Brand Name: AS LVP 20D LOW SORB 2SS 0.2M CV
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10508920
• MDR Text Key: 206368173
• Report Number: 9616066-2020-02692
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403232343
• UDI-Public: 10885403232343
• 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: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/01/2023
• Device Model Number: 11532269
• Device Catalogue Number: 11532269
• Device Lot Number: 20065136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other