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

Model Number	HS-003
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The air-in-line issue was confirmed.The device was tested by the distributor on 04/18/2019 and a hole was found at the distal end of the connector site of the administration set cassette.The affected device did not meet the specification and was discarded by the distributor on 04/18/2019.
Event or Problem Description
Infutronix received an air-in-line issue with the administration set on (b)(6) 2019 from a distributor.On (b)(4) 2019, a distributor representative received information from a colleague who reported the complaint on behalf of the user facility that the user facility "had several issues with nimbus iv sets not performing properly".It was also reported that "a small amount of air was present in these sets, the nurses caught it right away, and there was no harm to patients".The lot number of the affected device was unknown.No event date was provided to infutronix.Two affected sets would be returned to the distributor for examination; they are reported under this mdr and mdr #3011581906-2019-00006.

• 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: 8642591
• Report Number: 3011581906-2019-00007
• Device Sequence Number: 13954495
• Product Code: FPA
• UDI-Device Identifier: 00817170020024
• UDI-Public: 00817170020024
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140783
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2019

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 Model Number: HS-003
• Device Catalogue Number: HS-003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1