MAUDE Adverse Event Report: CAREFUSION ALARIS SECONDARY ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MS3500-15

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2019

Event Type  malfunction  

Manufacturer Narrative

Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.

Event Description

It was reported that when amiodarone ivpb was priming the secondary iv tubing fell apart from the spike.Patient impact or delay was not reported.

Manufacturer Narrative

Additonal information added to: d4,g4, and h4.

Event Description

It was reported that when amiodarone ivpb was priming the secondary iv tubing fell apart from the spike.Patient impact or delay was not reported.

• Brand Name: ALARIS SECONDARY ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9497745
• MDR Text Key: 177012373
• Report Number: 9616066-2019-03711
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403222610
• UDI-Public: 10885403222610
• Combination Product (y/n): N
• PMA/PMN Number: K051499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2021
• Device Model Number: MS3500-15
• Device Catalogue Number: MS3500-15
• Device Lot Number: 18115872
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1