MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-27 for LEVEL 1? H-1200 FAST FLOW FLUID WARMER H1200 manufactured by Smiths Medical Asd; Inc..
[185193544]
Serial number search in manufacturer oracle database did not result in any information. No device manufacture date available. There are also a total of 8 files related to each other as faults occured to each: 3012307300-2020-02149-0067812. 3012307300-2020-02150-0068829. 3012307300-2020-02151-0068832. 3012307300-2020-02153-0068837. 3012307300-2020-02154-0068838. 3012307300-2020-02155-0068840. 3012307300-2020-02156-0068841.
Patient Sequence No: 1, Text Type: N, H10
[185193545]
Information was received indicating that the during a patient code, pressure chambers to a smiths medical level 1? H-1200 fast flow fluid warmer would not fully empty 250-350ml blood bags. It was reported that there seemed to be a larger gap on the door that hindered the chambers from completely hindering emptying. There was also an indication that the flow rate was much slower than normal. There were no reported adverse effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02152 |
| MDR Report Key | 9887355 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-20 |
| Date Mfgr Received | 2020-02-21 |
| Date Added to Maude | 2020-03-27 |
| 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 | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE N |
| Manufacturer City | MINNEAPOLIS,, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 3833310 |
| Manufacturer G1 | SMITHS MEDICAL ASD INC |
| Manufacturer Street | 160 WEYMOUTH ST, |
| Manufacturer City | ROCKLAND, MA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEVEL 1? H-1200 FAST FLOW FLUID WARMER |
| Generic Name | WARMER, THERMAL, INFUSION FLUID |
| Product Code | LGZ |
| Date Received | 2020-03-27 |
| Model Number | H1200 |
| Catalog Number | H1200 |
| 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 N MINNEAPOLIS,, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |