MAUDE Adverse Event Report: CAREFUSION MICROBORE BI-FUSE EXTENSION SET, 2 IV CO; SET, EXTENSION, INTRAVASCULAR

Model Number	MZ9271
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: pri tubing; 10ml bd syringe ref (b)(4), lot number 724212a, exp 2020-08-20, 0.9% nacl, therapy date (b)(6) 2018.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
The customer reported the pump module alarmed for high pressure during an epinephrine drip.The patient¿s blood pressure was very labile and a second tubing and pump module was prepared to replace the infusion that alarmed.When changing the epinephrine line, the connection of the set to the picc was wet from a fluid leak; therefore, the new epinephrine infusion was connected to another port on the picc.There was no report of patient harm.
Additional Manufacturer Narrative
Additional information provided.The customer¿s report of a leak at the connection was not confirmed.Visual inspection of the set did not reveal any discernible signs of damage or abnormalities.Functional testing resulted in no leaking.A test pump infusion reached completion without any pump alarms or irregularities noted.The root cause of the reported failure was not determined.
Event or Problem Description
The customer reported the pump module alarmed for high pressure during an epinephrine drip.The patient¿s blood pressure was very labile and a second tubing and pump module were prepared to replace the infusion that alarmed.When changing the epinephrine line, the connection of the set to the picc was wet from a fluid leak; therefore, the new epinephrine infusion was connected to another port on the picc.There was no report of patient harm.

• Brand Name: MICROBORE BI-FUSE EXTENSION SET, 2 IV CO
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7731784
• Report Number: 9616066-2018-01190
• Device Sequence Number: 16779698
• Product Code: FPA
• UDI-Device Identifier: 10885403240744
• UDI-Public: 10885403240744
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2018

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 Model Number: MZ9271
• Device Catalogue Number: MZ9271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 11/12/2018
• 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, MZ1000-07, PICC, TD (B)(6) 2018; 8015, 8100, MZ1000-07, PICC, TD (B)(6) 2018
• Patient Age: 11 DA