MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-03 for CAPITAL BLOOD/FLUID WARMER FW603 manufactured by Stryker Medical-kalamazoo.
[37665743]
The customer reported that they were running saline through a fluid warmer and the temperature the machine was running at was approximately 47 degrees celsius which exceeded that stated on the machine of 42 degrees celsius. The device was switched off and another device was used to complete the case. The patient was not affected and no adverse consequence or clinically relevant delay in treatment was reported.
Patient Sequence No: 1, Text Type: D, B5
[40739962]
This issue was not confirmed as the device was not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[40739963]
The customer reported that they were running saline through a fluid warmer and the temperature the machine was running at was approximately 47 degrees celsius which exceeded that stated on the machine of 42 degrees celsius. The device was switched off and another device was used to complete the case. The patient was not affected and no adverse consequence or clinically relevant delay in treatment was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2016-00024 |
| MDR Report Key | 5408042 |
| Date Received | 2016-02-03 |
| Date of Report | 2016-01-07 |
| Date of Event | 2016-01-04 |
| Date Mfgr Received | 2016-01-07 |
| Date Added to Maude | 2016-02-03 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BRIAN THOMPSON |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal | 49002 |
| Manufacturer Phone | 2693292100 |
| Manufacturer G1 | STRYKER MEDICAL-KALAMAZOO |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPITAL BLOOD/FLUID WARMER |
| Generic Name | DEVICE, WARMING. BLOOD AND PLASMA |
| Product Code | KZL |
| Date Received | 2016-02-03 |
| Catalog Number | FW603 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER MEDICAL-KALAMAZOO |
| Manufacturer Address | 3800 EAST CENTRE AVENUE PORTAGE MI 49002 US 49002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-03 |