MAUDE Adverse Event Report: CAREFUSION SD EXT SET MICRO DEHP-FREE; INTRAVASCULAR ADMINISTRATION SET

Model Number 10031776

Device Problem Leak/Splash (1354)

Patient Problem Death (1802)

Event Date 09/10/2020

Event Type  Death  

Manufacturer Narrative

Date of death: the actual date of death is unknown.On (b)(6) 2020 has been used for this field.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 3ss cv was used on a covid-19 positive patient who died.The following information was provided by the initial reporter: material no: 10031776 ; batch no: 20065112.It was reported that a product failure with item 10031776 may have resulted in a patient death.Bd rep response 14-sep-2020: "i spoke with (b)(6) at (b)(6) this past thursday and they do have one of the tubing sets that failed.Since this tubing was connected to a patient that was covid-19 positive, how do we go about sending that into bd?" customer response 11-sep-2020: "sending this request to the appropriate staff for information based on request below." "i received a phone call from xxxxxxxxxxxx at (b)(6) health stating that there was a product failure with item 10031776 which may have resulted in a patient death.I spoke with her at 10:00 am regarding this event.Xxxxxxx is in supply chain at (b)(6) and can put us in touch with the end users who experienced the event and provide more detail.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 10/06/2020 investigation conclusion it was reported that a product failure with item 10031776 may have resulted in a patient death.Received one used extension set model 10031776 lot 20065112.Also received fifty new extension sets model 10031776 lot 20065112.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection found a lateral crack in the event sample¿s female luer wall (p/n 630-01363) located at the top end of the female luer opposite of the luer gate.The location of the luer gate on the female luer (below the ¿wings¿) indicates that this female luer was manufactured after the change order where the injection gate was moved to a lower location to help mitigate and prevent female luer cracks.No signs of visible over torque marks were observed on the female luer.No other damages or anomalies were observed with the set or the components during initial visual inspection.Visual inspection of the fifty associated sets as received did not observe any damages or cracks with any of the components.Functional testing was performed by attaching a 10ml lab syringe filled with bleach water to the event set¿s female luer.The syringe plunger was gently depressed and a leak was observed where the noted crack was found.The syringe was disconnected from the set and the set was pressure tested using air pressure (pounds per square inch or psi, unit of pressure) while submerged underwater (per dir # 10000360033 ¿ iv disposable leak test method).The air supply regulator was set to a pre-pressure level of 5psi +/- 1 psi, ensuring air is flowing.The set was attached to the output of the air pressure regulator with a closed lab stopcock at the end of the set and air bubbles were observed leaking from the previously noted female luer damage at 5psi.A leak is defined as one air bubble approximately every 5 seconds.No other leaks or issues were observed.Bd supplier quality engineering manufacturing was notified of the component failure and a quality systems supplier notification memo was issued to the filter supplier (borla).15 of the 50 associated sets including the event sample were sent to bd global materials coe lab for further analysis to determine the possibility of material deficiency (gml-20-10-006).The analysis was performed using optical microscopy, sem images, ftir, and differential scanning calorimetry (dsc) to identify or eliminate possible root causes of the cracked female luer.The customer¿s report of a product failure was confirmed due to lateral cracks found in the event model 10031776¿s female luer.The root cause of the female luer cracks were not definitively determined.The proximate cause of female luer cracks were identified to be a result of an excess application of external force applied between mating components.See h10.

Event Description

It was reported that as lvp 20d 3ss cv was used on a covid-19 positive patient who died.The following information was provided by the initial reporter: material no: 10031776 batch no: 20065112 it was reported that a product failure with item 10031776 may have resulted in a patient death.Bd rep response (b)(6) 2020: "i spoke with (b)(6) at anmed this past thursday and they do have one of the tubing sets that failed.Since this tubing was connected to a patient that was covid-19 positive, how do we go about sending that into bd?" customer response (b)(6) 2020: "sending this request to the appropriate staff for information based on request below." "i received a phone call from xxxxxxxxxxxx at anmed health stating that there was a product failure with item 10031776 which may have resulted in a patient death.I spoke with her at 10:00 am regarding this event.Xxxxxxx is in supply chain at anmed and can put us in touch with the end users who experienced the event and provide more detail.".

• Brand Name: EXT SET MICRO DEHP-FREE
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10605984
• MDR Text Key: 209153920
• Report Number: 9616066-2020-02831
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403234095
• UDI-Public: 10885403234095
• Combination Product (y/n): N
• PMA/PMN Number: K790108
• 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: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/05/2023
• Device Model Number: 10031776
• Device Catalogue Number: 10031776
• Device Lot Number: 20065112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death