RANGER BLOOD/FLUID WARNING SYSTEM WITH SMARTHEAT TECHNOLOGY HIGH FLOW DISPOSABLE 24355

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-11 for RANGER BLOOD/FLUID WARNING SYSTEM WITH SMARTHEAT TECHNOLOGY HIGH FLOW DISPOSABLE 24355 manufactured by 3m.

Event Text Entries

[72876158] Our emergency department and icu teams have experienced recurrent product malfunction while using the 3m ranger pressure infuser (model 145) and blood warmer (model 245) with our trauma population. In 2017, 7 events have been reported and there have been additional general concerns shared with our clinical education and engineering teams. When attempting to infuse using the equipment's pressure infusion system with the appropriate high flow disposable set tubing (product number 24355), the tubing connections above and below the warming cassette become disconnected or loosen, resulting in either a leak or forceful spray of blood product onto clinicians, patients, and other needed equipment. This has happened in cases after clear confirmation that line connections were checked, tightened, and primed per manufacturer guidelines. The tubing spike, having been double checked for proper connection, also becomes dislodged resulting in forceful blood spray. Per clinicians, the infusion rate for this device is often between 50 and 100 ml/min using a minimum of an 18 gauge piv. Marketing materials represent infusion rates of up to 500 ml/min. While the product is infusing, clinicians have observed the blood product bag collapsing in on itself despite the pressure infuser bladder being fully inflated. This impedes full transfusion and reduces equal pressure, resulting in observed decreased infusion rate. Regarding sprayed blood product, we are concerned about the potential infection risk to our employees, and the waste of blood product in a trauma environment. Regarding infusion rate and stopped infusion due to sprayed product, we are concerned this might impact the efficiency of resuscitating our patients.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5069065
MDR Report Key6489420
Date Received2017-04-11
Date of Report2017-04-11
Date Added to Maude2017-04-13
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationATTORNEY
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameRANGER BLOOD/FLUID WARNING SYSTEM WITH SMARTHEAT TECHNOLOGY HIGH FLOW DISPOSABLE
Generic NameRANGER HIGH FLOW INFUSION TUBING
Product CodeFKB
Date Received2017-04-11
Model Number24355
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
Manufacturer3M
Manufacturer AddressST. PAUL MN 55144 US 55144


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-04-11

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