MAUDE Adverse Event Report: CAREFUSION ALARIS EXTENSION SET; FILTER, INFUSION LINE

Model Number 20029E

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2015

Event Type  malfunction  

Manufacturer Narrative

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 a leak from a vent hole on the back of a filter during a tpn infusion, dosage and rate not provided.There was no patient harm.

Manufacturer Narrative

(b)(4).The customer¿s report of a leak at the filter on the extension set was not confirmed.Visual inspection of the suspect extension set showed no damage or other issues.Visual inspection of the concomitant primary set showed a tear in the silicone segment.No other damage or issues were observed on the samples.Functional testing and pressure testing were performed and resulted in no leaking from either set.The root cause of the reported leak at the filter was not identified.

Manufacturer Narrative

The customer¿s report of a leak at the filter was confirmed.Visual inspection observed sticky orange medication on the filter vent.Further visual inspection of the filter vent observed its membrane to be wetted out.No other damages or any issues were observed.Functional testing was performed by attempting to reprime the set with a lab syringe filled with blue dyed fluid and it was observed that the fluid leaked out from the vent of the filter.A pressure test of the reprimed set was also performed and it was observed that the fluid also leaked out from the vent at around 5psi.The pressure was increased to 30psi; however there were no additional leaks from anywhere else on the set.The probable cause of a leak at the filter was due to the filter vent membrane being wetted out.

Manufacturer Narrative

Correction to initial reporter address.

• Brand Name: ALARIS EXTENSION SET
• Type of Device: FILTER, INFUSION LINE
• 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: stephen bilello ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 5505291
• MDR Text Key: 40782524
• Report Number: 9616066-2016-00441
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K801614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20029E
• Device Catalogue Number: 20029E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2016
• 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