RANGER 245

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-12 for RANGER 245 manufactured by 3m Company.

Event Text Entries

[119938277] The ranger blood warmers are not fluid-resistant and there is a chance that fluids can intrude into the device. If there is spillage or the cassette breaks, then fluid and/or blood intrudes into the unit which could compromise the electrical integrity of the device. If electrical integrity is compromised - it could result in potential harm to the operator as well as the patient. Manufacturer response for warmer, blood/fluid, ranger 245 (per site reporter): manufacturer provided us with replacement units that are also compromised.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 7868002
• MDR Report Key: 7868002
• Date Received: 2018-09-12
• Date of Report: 2018-08-23
• Date of Event: 2018-08-06
• Report Date: 2018-08-23
• Date Reported to FDA: 2018-08-23
• Date Reported to Mfgr: 2018-09-12
• Date Added to Maude: 2018-09-12
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: RANGER 245
• Generic Name: DEVICE, WARMING. BLOOD AND PLASMA
• Product Code: KZL
• Date Received: 2018-09-12
• Model Number: 245
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: 6 YR
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: 3M COMPANY
• Manufacturer Address: 3M CENTER, 2510 CONWAY AVE. BLDG. 275-5W-06 SAINT PAUL MN 55144 US 55144

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-09-12