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

Model Number 2420-0007

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2020

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 reported feedback suggests that there was a ballooned silicone segment.From the reported information there are no indications of serious injury to the patient or user as a result of this incident.

Manufacturer Narrative

A sample was not required for investigation of this feedback as the customer provided a photograph of the affected sample.Analysis of the photograph confirmed the customer's experience with the silicone pumping segment identified to have bulged.No further information was available to assist the investigation in this instance.The details of this feedback were forwarded to the manufacturing site for investigation.In this instance a lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.Please note, ballooning of the silicone segment is not a manufacturing defect and is typically caused by an excessively high internal pressure.Previous investigations have identified that administering an iv push without clamping the line above the injection port can create an internal pressure high enough to cause this effect.Without further information, it has not been possible to determine what factors may have led to the customer¿s experience in this instance.A review of the database indicates that there have been a small number of similar complaints, however they have not been attributable to a product defect or manufacturing issue.H3 other text : see section h.10.

Event Description

The reported feedback suggests that there was a ballooned silicone segment.From the reported information there are no indications of serious injury to the patient or user as a result of this incident.

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9829427
• MDR Text Key: 191586566
• Report Number: 9616066-2020-00803
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1