ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX)

MDR report key: 6986544 · Received October 30, 2017

Report

Report Number: 3011581906-2017-00003
Event Type: Malfunction
Date Received: October 30, 2017
Report Date: October 2, 2017
Manufacturer: INFUTRONIX LLC
Product Code: FPA
UDI-DI: 00814371020198
PMA / PMN Number: K140783
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

THE MANUFACTURER IS IN THE PROCESS OF SENDING THE AFFECTED DEVICE TO THE CONTRACT SUPPLIER.

Additional Manufacturer Narrative · 1

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).

Additional Manufacturer Narrative · 1

THIS FOLLOW-UP CORRECTS A TYPO MADE: PMA/510(K) SECTION FROM THE INITIAL SUBMISSION. THE 510(K) NUMBER SHOULD BE K140783.

Description of Event or Problem · 1

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.

Description of Event or Problem · 1

THIS IS A SECOND FOLLOW-UP FOR THE INITIALLY FILED MDR 3011581906-2017-00003.

Description of Event or Problem · 1

THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR 3011581906-2017-00003.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
766938	ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX)	IV ADMINISTRATION SET	FPA	INFUTRONIX LLC	HS-004	UNKNOWN	00814371020198

Patients

Seq	Age	Sex	Outcome	Treatment
1