MAUDE Adverse Event Report: CAREFUSION 40 IN EXT W/2 VLV PORTS; SET, EXTENSION, INTRAVASCULAR

Model Number 37262E

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

Patient Problem Cardiac Arrest (1762)

Event Date 05/07/2020

Event Type  Injury  

Manufacturer Narrative

Investigation summary: it was reported that the extension tubing on the iv was leaking at an infusion port.The port had a small slit in it which caused the patient to loose his blood pressure requiring several minutes of cpr.Received one used extension set model 30263e lot unknown.The reported model 37262e that was in use during the customer event was not returned for evaluation.The set was visually inspected for kinks, incomplete bonding engagements, holes/ tears in the tubing or damages to the components.Blood was observed within the distal tubing of the extension set.No anomalies or evidence of damages under magnification were observed at the components or throughout the set during initial visual inspection.Functional testing was performed by attaching one 10ml bd syringe filled with blue dye water at the extension set¿s female luer and one 18g cannula was attached at the set¿s male luer.The syringe plunger was gently depressed to flush out the remaining fluids within the set and there were no leaks or issues observed at any of the smartsite components or between the mating components.The syringe was detached from the female luer and attached to each of the set¿s smartsites while attempting to flush the set at each injection port component; no leaks or any issues were observed at the connections during each flush.The syringe was detached and the extension set was attached to a primary lab iv set¿s male luer with an iv bag filled with blue dye water.Model 30263e reprimed successfully via gravity with no signs of leaks or anomalies.The sets were then loaded into a lab pump module for a primary infusion.The infusion was programmed for a rate of 125ml/hr and vtbi of 125ml.The infusion completed with no alarms, leaks, or any issues.The extension set was pressure tested while submerged underwater (per dir (b)(4) ¿ iv disposable leak test method).Air pressure was incrementally increased from 5 psi to 30 psi.No leaks or anomalies were observed at any of the components or throughout the set.Model 30263e¿s female/male luer ports were measured and found to be within iso standards with the female/male go/nogo gauges.Equipment used (measurement and testing performed on 22-jun-20).8015 alaris pcu 1.5, eq08330, calibration due date: 05-aug-20.8100 alaris system lvp, eq08327, calibration due date: 16-nov-20.Air pressure regulator with pressure gauge, eq00138, calibration due date: 02-oct-20.Female go/no go gauge, eq08248, calibration due date: 12-sep-20.Male go/no go gauge, eq08244, calibration due date: 12-sep-20.Optical ram-cnc, eq08204, calibration due date: 12-aug-20.A device history record could not be performed due to no lot number was provided by the customer.Root cause analysis: the customer¿s report that the extension tubing on the iv was leaking at an infusion port was not confirmed.The root cause of the customer¿s observed event was not identified as we were unable to reproduce any issues with the set as it performed as expected during functional testing and pressure testing.The customer also reported that the port (smartsites) had a small slit in it was confirmed.However, the slit on the injection port of the blue piston of the smartsite is by design to allow fluid to flow through the slit when a mating component is attached.No leaks or anomalies were observed during functional and pressure testing.

Event Description

It was reported that 40 in ext w/2 vlv ports was leaking.There was a hole causing blood pressure lost and requiring cpr to be performed.The following information was provided by the initial reporter: material no.: 37262e batch no: unknown.It was reported that the extension tubing on the iv was leaking at an infusion port.The port had a small slit in it which caused the patient to loose his blood pressure requiring several minutes of cpr.Pt was on a levophed gtt.A central line was placed.I was transferring his levophed gtt to the central line.The femoral tlc began to back up with blood and would not infuse.It was noted that the extension tubing on the iv was leaking at an infusion port.The port has a small slit in it.This caused the patient to loose his blood pressure and require several minutes of cpr.He did have rosc.The extension tubing was removed, placed in a biohazard bag and placed in the supervisors office.Covid 19 negative.

Event Description

It was reported that 40 in ext w/2 vlv ports was leaking.There was a hole causing blood pressure lost and requiring cpr to be performed.The following information was provided by the initial reporter: material no.: 37262e batch no.: unknown.It was reported that the extension tubing on the iv was leaking at an infusion port.The port had a small slit in it which caused the patient to loose his blood pressure requiring several minutes of cpr.Pt was on a levophed gtt.A central line was placed.I was transferring his levophed gtt to the central line.The femoral tlc began to back up with blood and would not infuse.It was noted that the extension tubing on the iv was leaking at an infusion port.The port has a small slit in it.This caused the patient to loose his blood pressure and require several minutes of cpr.He did have rosc.The extension tubing was removed, placed in a biohazard bag and placed in the supervisors office.Covid 19 negative.

Manufacturer Narrative

The following fields have been updated with corrections: h.6.Investigation summary: it was reported that the extension tubing on the iv was leaking at an infusion port.The port had a small slit in it which caused the patient to loose his blood pressure requiring several minutes of cpr.Received one used extension set model 37262e lot unknown.The set was visually inspected for kinks, incomplete bonding engagements, holes/ tears in the tubing or damages to the components.Blood was observed within the distal tubing of the extension set.No anomalies or evidence of damages under magnification were observed at the components or throughout the set during initial visual inspection.Functional testing was performed by attaching one 10ml bd syringe filled with blue dye water at the extension set¿s female luer and one 18g cannula was attached at the set¿s male luer.The syringe plunger was gently depressed to flush out the remaining fluids within the set and there were no leaks or issues observed at any of the smartsite components or between the mating components.The syringe was detached from the female luer and attached to each of the set¿s smartsites while attempting to flush the set at each injection port component; no leaks or any issues were observed at the connections during each flush.The syringe was detached and the extension set was attached to a primary lab iv set¿s male luer with an iv bag filled with blue dye water.Model 30263e reprimed successfully via gravity with no signs of leaks or anomalies.The sets were then loaded into a lab pump module for a primary infusion.The infusion was programmed for a rate of 125ml/hr and vtbi of 125ml.The infusion completed with no alarms, leaks, or any issues.The extension set was pressure tested while submerged underwater (per dir #10000339917 ¿ iv disposable leak test method).Air pressure was incrementally increased from 5 psi to 30 psi.No leaks or anomalies were observed at any of the components or throughout the set.Model 30263e¿s female/male luer ports were measured and found to be within iso standards with the female/male go/nogo gauges.Equipment used (measurement and testing performed on (b)(6) 20) - 8015 alaris pcu 1.5, eq08330, calibration due date: (b)(6)-20 - 8100 alaris system lvp, eq08327, calibration due date: (b)(6)20 - air pressure regulator with pressure gauge, eq00138, calibration due date: (b)(6)-20 - female go/no go gauge, eq08248, calibration due date:(b)(6)20 - male go/no go gauge, eq08244, calibration due date: (b)(6)-20 - optical ram-cnc, eq08204, calibration due date: (b)(6)-20 a device history record could not be performed due to no lot number was provided by the customer.Root cause analysis: the customer¿s report that the extension tubing on the iv was leaking at an infusion port was not confirmed.The root cause of the customer¿s observed event was not identified as we were unable to reproduce any issues with the set as it performed as expected during functional testing and pressure testing.The customer also reported that the port (smartsites) had a small slit in it was confirmed.However, the slit on the injection port of the blue piston of the smartsite is by design to allow fluid to flow through the slit when a mating component is attached.No leaks or anomalies were observed during functional and pressure testing.Investigation conclusion: visual inspection observed blood within the distal tubing of the extension set.No anomalies or evidence of damages under magnification were observed at the components or throughout the set during initial visual inspection.H3 other text : see h.10.

• Brand Name: 40 IN EXT W/2 VLV PORTS
• Type of Device: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10193107
• MDR Text Key: 202860606
• Report Number: 9616066-2020-02017
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403235276
• UDI-Public: 10885403235276
• Combination Product (y/n): N
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37262E
• Device Catalogue Number: 37262E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 20200507.
• Patient Outcome(s): Required Intervention