MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-11-03 for LEVEL 1? FAST FLOW FLUID WARMER DISPOSABLE ADMINISTRATION SETS D-300 manufactured by Smiths Medical Asd, Inc..
[59134141]
Customer has not returned the device to the manufacturer for device evaluation. If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[59134142]
It was reported that a level 1 fast flow fluid warmer disposable administration set was used during resuscitation when the blood product was severely delayed during a rapid blood transfusion. It was unknown whether a central line or a peripheral intravascular catheter was used. No medical intervention was required and no patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2016-00241 |
| MDR Report Key | 6077056 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-11-03 |
| Date of Report | 2016-10-12 |
| Date of Event | 2016-09-17 |
| Date Mfgr Received | 2016-10-12 |
| Device Manufacturer Date | 2016-03-01 |
| Date Added to Maude | 2016-11-03 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA PERZ |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833074 |
| Manufacturer G1 | SMITHS HEALTHCARE MFG |
| Manufacturer Street | S.A. DE C.V. AVE CALIDAD NO. 4 PARQUE INDUSTRIAL INTERNACIONA |
| Manufacturer City | TIJUANA, B.C. 22425 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22425 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEVEL 1? FAST FLOW FLUID WARMER DISPOSABLE ADMINISTRATION SETS |
| Generic Name | DEVICE, WARMING. BLOOD AND PLASMA |
| Product Code | KZL |
| Date Received | 2016-11-03 |
| Catalog Number | D-300 |
| Lot Number | 3151180 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-03 |