MAUDE Adverse Event Report: CAREFUSION ALARIS MULTI-FUSE EXTENSION SET; SET, EXTENSION, INTRAVASCULAR

Model Number	MZ9275
Medical Device Problem Codes	Break (1069); Material Separation (1562); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	10/07/2019
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
It was reported that trifuse extension set broke off during use.Although requested, no further details were provided by the customer for this event.
Event or Problem Description
It was reported that trifuse extension set broke off during a continuous infusion of vasopressin.The customer stated the extension set broke at the connection to an unspecified mating device.There was no patient harm or medical interventions required per customer.The event occurred in the cticu.Although requested, no further details were provided by the customer.
Additional Manufacturer Narrative
Additional information added to: b7, & d11.Correction; h.6.(patient code and device code).The customer¿s report that the trifuse extension set broke off (separated) was confirmed.Visual inspection observed that the extension set was separated at the engagement between the tubing to one of the four bonded maxzero¿s outlet ports.Closer inspection observed that the tubing had insufficient solvent applied at the engagement during manufacturing process.Functional testing could not be performed due to the set¿s separation and obvious leaking that would occur.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.No damages or other anomalies were observed.Dimensional testing was performed on the outer diameter of the separated tubing and was measured to be within the specifications.The root cause was identified as a manufacturing issue for insufficient solvent being applied at the engagement of the tubing due to equipment and/or operator error.

• Brand Name: ALARIS MULTI-FUSE EXTENSION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9281173
• Report Number: 9616066-2019-03075
• Device Sequence Number: 16844430
• Product Code: FPA
• UDI-Device Identifier: 10885403240768
• UDI-Public: 10885403240768
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/27/2021
• Device Model Number: MZ9275
• Device Catalogue Number: MZ9275
• Device Lot Number: 18096966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 01/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8015,8100.; PRI TUBING, THERAPY DATE (B)(6) 2019.; PRI TUBING, THERAPY DATE (B)(6) 2019