MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE SET SYRINGE ADAPTER; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 10010483

Device Problem Material Integrity Problem (2978)

Patient Problem No Information (3190)

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

It was reported that the syringe adapter set is snapping off at the tip.

Manufacturer Narrative

The customer¿s report that the syringe adapter set is snapping off at the tip was confirmed based on both the customer provided photo (showing the vented spike component separated from the upper fitment component of the pump chamber assembly) and inspection of the partial set.Visual inspection observed that the expected vented spike component was broken off from the upper fitment of the pump chamber assembly component and not received for inspection.Further visual inspection of the upper fitment of the pump chamber assembly noted the broken off mating piece of the vented spike component within.Inspection under magnification of the broken off mating piece surface observed the breakage to be rough and uneven.The nature of the breakage indicates a ductile fracture (vs.A brittle fracture) that is typically caused by an external lateral force.Functional testing was not performed due to the obvious damage.The root cause of the syringe adapter set snapped off at the tip was not determined.

Event Description

The customer notified bd with a reported issue that the syringe adapter set is snapping off at the tip.

• Brand Name: ALARIS PUMP MODULE SET SYRINGE ADAPTER
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8695960
• MDR Text Key: 147902804
• Report Number: 9616066-2019-01559
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403232602
• UDI-Public: 10885403232602
• Combination Product (y/n): N
• PMA/PMN Number: K934095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2021
• Device Model Number: 10010483
• Device Catalogue Number: 10010483
• Device Lot Number: 18046888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015,8100,SYRINGE; 8015,8100,SYRINGE