MAUDE Adverse Event Report: INFUTRONIX LLC ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX); IV ADMINISTRATION SET

Model Number	HS-004
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer is in the process of sending the affected device to the contract supplier.
Event or Problem Description
The user reported a leaking issue with the administration set to infutronix on (b)(6) 2017." 1 nimbus flex ii administration set-it1032 with check valve leaked about 20 cc's 5fu form what appeared to be the air eliminating 1.2 micron filter.The rn noticed this and the set was provided to pharmacy that saved the set and will return for root cause." no patient injury or harm occured for this case.
Additional Manufacturer Narrative
This follow-up corrects a typo made: pma/510(k) section from the initial submission.The 510(k) number should be k140783.
Event or Problem Description
This is a follow-up for the initially filed mdr 3011581906-2017-00003.
Additional Manufacturer Narrative
The device was evaluated by (b)(4), inc on 11/09/2017.The user-reported leaking issue was confirmed.The details can be found in the report.(b)(4).
Event or Problem Description
This is a second follow-up for the initially filed mdr 3011581906-2017-00003.

• Brand Name: ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX)
• Common Device Name: IV ADMINISTRATION SET
• Manufacturer (Section D): INFUTRONIX LLC; 177 pine street; natick MA 01760
• MDR Report Key: 6986544
• Report Number: 3011581906-2017-00003
• Device Sequence Number: 1210771
• Product Code: FPA
• UDI-Device Identifier: 00814371020198
• UDI-Public: 00814371020198
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140783
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2017

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: HS-004
• Device Catalogue Number: HS-004
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2017
• Supplement Date Received by Manufacturer: 10/02/2017; 10/02/2017
• Initial Report FDA Received Date: 10/30/2017
• Supplement Report FDA Received Date: 12/13/2017; 01/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1