APEX? AX1000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-12 for APEX? AX1000 manufactured by B. Braun Medical Inc.

Event Text Entries

[187073049] This report has been identified as b. Braun medical inc. Internal report number (b)(4). The investigation is ongoing at this time. A follow up will be submitted when the investigation results become available.
Patient Sequence No: 1, Text Type: N, H10


[187073050] As per b. Braun implementation specialist: customer reported while compounding an order the pharmacist noticed mvi dispensing out of sequence. Mvi was located on port 19 and should have dispensed fourth in the sequence. The pump was immediately shut down and the bag was scrapped. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1641965-2020-00004
MDR Report Key9699250
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-12
Date of Report2020-02-12
Date of Event2019-01-25
Date Mfgr Received2020-01-25
Date Added to Maude2020-02-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. JONATHAN SEVERINO
Manufacturer Street861 MARCON BLVD.
Manufacturer CityALLENTOWN PA 18109
Manufacturer CountryUS
Manufacturer Postal18109
Manufacturer Phone4847197287
Manufacturer G1B. BRAUN MEDICAL INC
Manufacturer Street1601 WALLACE DRIVE, SUITE 150
Manufacturer CityCARROLLTON TX 750066690
Manufacturer CountryUS
Manufacturer Postal Code750066690
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAPEX?
Generic NameCOMPOUNDER
Product CodeNEP
Date Received2020-02-12
Model NumberAX1000
Catalog NumberAX1000
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerB. BRAUN MEDICAL INC
Manufacturer Address1601 WALLACE DRIVE, SUITE 150 CARROLLTON TX 750066690 US 750066690


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-12

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