MAUDE Adverse Event Report: CAREFUSION MAXPLUS EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MPX9103

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.

Event Description

It was reported that a extension set tubing separated when attached to the patient at the point of connection between the y-site port and the male luer.It was still inserted into the patient¿s vein.

Manufacturer Narrative

Additional information added; h.6.(device code).Correction; h.6.(patient code).****************************************************** the customer¿s report that the extension set tubing separated was confirmed based on the provided photos.The reported suspect extension set sample was not received for evaluation.An unopened extension set sample was received instead.Visual inspection, pressure testing, and handling of the received sample observed no separation or issue.Visual inspection observed no separation or issue.The sample was visually inspected for kinks, holes/tears in the tubing or damages to the components.No issue was observed.The root cause was not identified.

Event Description

It was reported that a extension set tubing separated when attached to the patient at the point of connection between the y-site port and the male luer.It was still inserted into the patient¿s vein.Although requested, there has been no impact to patient response or additional event information made available to date.

• Brand Name: MAXPLUS EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9532727
• MDR Text Key: 193959404
• Report Number: 9616066-2019-03770
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403237294
• UDI-Public: 10885403237294
• 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: 12/09/2019

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 Model Number: MPX9103
• Device Catalogue Number: MPX9103
• Device Lot Number: 19105069
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1