MAUDE Adverse Event Report: CAREFUSION TEXIUM CLOSED MALE LUER WITH FEMALE CAP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 10012241-0500

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/28/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: hospira primary and secondary tubing; plum pumps.Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.

Event Description

The customer reported that a secondary infusion of cytoxan was noted to be alarming constantly on the non-bd pump while using a non-bd primary and secondary tubing set.The texium connector was attached to the secondary non-bd tubing onto the non-bd primary tubing.A smartsite add-on bag access device was also used with the tubing while connected to a patient.The customer alleges that the texium connector was causing the non-bd pump to alarm for occlusion.There was no patient harm however the issue caused a delay in the patient's discharge following the infusion.

Manufacturer Narrative

Cont'd from medical devices: 1000ml fresenrus kabi bag lot number 14ll347 exp 10/19 cytoxan; 100ml hospira bag ndc 0409-7984-23 lot number 84-008-jt exp 1 dec 2019 0.9% nacl.Correction: please disregard section in follow-up report #1.Although the product was used off-label the event still resulted in prolonged hospitalization and therefore remains an adverse event.The customer¿s report that the texium connector was causing the non-bd pump to alarm for occlusion was not confirmed.The texium and sets were visually inspected and no anomalies were observed.Functional and pressure testing resulted in fluid flowing freely with no signs of occlusion or leaking.The root cause of the customer's report could not be determined.The texium is intended to only be attached to a smartsite valve.

Event Description

The 500ml of cytoxan (1335mg) was programmed to infuse at 1000ml/hr.

Manufacturer Narrative

This file is no longer considered reportable as it was determined the texium was being use in an off-label manner.Please disregard the initial submission.

• Brand Name: TEXIUM CLOSED MALE LUER WITH FEMALE CAP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 7524215
• MDR Text Key: 108601403
• Report Number: 9616066-2018-00610
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10012241-0500
• Device Catalogue Number: 10012241-0500
• Other Device ID Number: 10885403221705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization
• Patient Age: 64 YR