MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-18 for 3M? RANGER? BLOOD/FLUID WARMING SYSTEM 24365 manufactured by 3m Health Care.
[187709563]
No patient specific information was provided. No patient injury reported. Corrective action has been implemented for bubble trap leaks. Lot hw8238 was produced prior to implementation of corrective action.
Patient Sequence No: 1, Text Type: N, H10
[187709564]
A hospital reported the 3m? Ranger? Blood/fluid warming system high flow with auto-venting bubble trap model 24365 leaked at the auto venting bubble trap. Type of liquid alleged to have leaked was not specified. No patient injury was alleged. No information was provided as to if the set was primed prior to use, or if a pressure device was used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2020-00019 |
| MDR Report Key | 9849065 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-05 |
| Date Added to Maude | 2020-03-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MS. DIANNE GIBBS |
| Manufacturer Street | 3M CENTER, BUILDING 275-5W-06 2510 CONWAY AVE |
| Manufacturer City | ST. PAUL, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 7379117 |
| Manufacturer G1 | NYPRO PRECISION ASSEMBLIES |
| Manufacturer Street | SOR JUANA INES DE LA CRUZ CD. INDUSTRIAL |
| Manufacturer City | TIJUANA, TIJUANA BAJA CALIFORNIA 22444 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22444 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M? RANGER? BLOOD/FLUID WARMING SYSTEM |
| Generic Name | HIGH FLOW DISPOSABLE TUBING |
| Product Code | BSB |
| Date Received | 2020-03-18 |
| Model Number | 24365 |
| Catalog Number | 24365 |
| Lot Number | HW8238 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 2510 CONWAY AVE ST. PAUL, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-18 |