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

Model Number MX4410

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.Patient demographics requested however not provided, customer provided that the patient was an adult.

Event Description

It was reported that during priming, it was observed that the set was missing the roller clamp.The event occurred in the endoscopy unit.An incomplete event date september reported.The customer confirmed that there was no patient involvement.

Manufacturer Narrative

The customer¿s report of missing roller clamp was confirmed.During visual inspection, it was observed that the roller clamp was missing below the proximal bill of material drawing.No further testing was performed.Functional testing was not performed as the customer's report was confirmed upon visual inspection.The root cause was identified as a manufacturing issue due to operator error.

Event Description

It was reported that during priming, it was observed that the set was missing the roller clamp.The event occurred in the endoscopy unit.An incomplete event date of (b)(6) was reported.The customer confirmed that there was no patient involvement.

• Brand Name: ALARIS ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9168709
• MDR Text Key: 161715176
• Report Number: 9616066-2019-02785
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403237454
• UDI-Public: 10885403237454
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/11/2019

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 Expiration Date: 04/30/2024
• Device Model Number: MX4410
• Device Catalogue Number: MX4410
• Device Lot Number: 19047081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1