MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-28 for 3M RANGER BLOOD/FLUID WARMING SYSTEM 24355 manufactured by 3m Company.
[181375967]
Patient was in surgery for a procedure. He required blood transfusion and was receiving blood via 3m ranger blood/ fluid warming system- high flow. Nursing and anesthesia heard a sudden loud noise and discovered the ranger tubing had cracked and blood was leaking out onto the floor. The transfusion was stopped through the ranger and plugged into another iv to continue infusion. The drip chamber cracked.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9769620 |
| MDR Report Key | 9769620 |
| Date Received | 2020-02-28 |
| Date of Report | 2020-01-16 |
| Date of Event | 2019-12-30 |
| Report Date | 2020-01-16 |
| Date Reported to FDA | 2020-01-16 |
| Date Reported to Mfgr | 2020-02-28 |
| Date Added to Maude | 2020-02-28 |
| 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 |
| 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 |
| Brand Name | 3M RANGER BLOOD/FLUID WARMING SYSTEM |
| Generic Name | WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION |
| Product Code | BSB |
| Date Received | 2020-02-28 |
| Model Number | 24355 |
| Catalog Number | 24355 |
| Lot Number | HX8388 |
| Device Availability | * |
| Device Age | 0 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-28 |