MAUDE Adverse Event Report: 3M HEALTH CARE 3M RANGER¿ BLOOD/FLUID WARMING SYSTEM STANDARD FLOW; STANDARD FLOW DISPOSABLE TUBING

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Death (1802); Patient Problem/Medical Problem (2688)

Event Date 03/12/2018

Event Type  Death  

Manufacturer Narrative

No patient information was provided.No lot number was provided.Without the lot number it is not possible to provide the expiration date, udi or manufacturer date.The initial reporter was noted as a nurse or doctor but no specific name was given to complete this section.The instructions for use includes the following caution: "do not exceed 300 mmhg pressure".Attempts are being made to obtain more information.End of report.

Event Description

A company representative during an in-service on (b)(6) 2018 was informed by a heath professional of an incident that had occurred one week prior (exact date not given).Incident involved the use of a 3m ranger¿ blood/fluid warming system standard flow to administer blood to a critical/dying patient.The cassette broke at the entry seam.No pressure infuser was being used.They performed hand squeezing on the cassette, so had to unhook the cassette and worked around it.It was reported the use of the device was not the cause of death to the patient.The product was not being used accordance with its instructions.

Manufacturer Narrative

Correction: date received by manufacturer corrected to 28-mar-2018.

• Brand Name: 3M RANGER¿ BLOOD/FLUID WARMING SYSTEM STANDARD FLOW
• Type of Device: STANDARD FLOW DISPOSABLE TUBING
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): NYPRO PRECISION ASSEMBLIES; sor juana ines de la cruz; cd. industrial; tijuana, tijuana baja california 22444 ; MX 22444
• Manufacturer Contact: linda johnsen ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517374376
• MDR Report Key: 7468621
• MDR Text Key: 106742318
• Report Number: 2110898-2018-00047
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K973741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 24200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death