FDA Adverse Event Malfunction Summary report: N

VISTA BASIC - IFVB

MDR report key: 6031369 · Received October 14, 2016

Report

Report Number: 9610825-2016-00651
Event Type: Malfunction
Date Received: October 14, 2016
Report Date: September 20, 2016
Manufacturer: B. BRAUN MELSUNGEN AG
Product Code: FRN
PMA / PMN Number: K003029
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN MELSUNGEN (THE MANUFACTURER), AND B. BRAUN MEDICAL INC. (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE VOLUMETRIC ACCURACY WAS TESTED THREE TIMES AT 60ML/HR AND 1 HOUR (60ML) AND THE PUMP TESTED IN SPECIFICATIONS. BASED ON THE RESULTS OF THE INVESTIGATION, THE PUMP OPERATED AS INTENDED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

Additional Manufacturer Narrative · 0

EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN MELSUNGEN (THE MANUFACTURER), AND B. BRAUN MEDICAL INC. (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE DEVICE INVOLVED HAS BEEN RECEIVED FOR EVALUATION AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

Description of Event or Problem · 0

AS REPORTED BY THE USER FACILITY: REPORTS UNDER INFUSION. SET PUMP FOR 60ML PER HOUR INFUSED 4824 ML. REPORTS NO PATIENT INJURY. LIMITED INFORMATION PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
681595	VISTA BASIC - IFVB	INFUSION PUMP	FRN	B. BRAUN MELSUNGEN AG		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1