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.
[37681868]
The customer reported a temperature control issue with the fluid warmer. They further reported that the temperature that the machine was warming to was approximately 47 degrees celsius, which appeared to exceed that which was stated by the machine 42 degrees celsius. This was noticed by staff who where observing that the machine was running at a higher temperature than it was set to. The machine was immediately switched off and another machine from the fleet was used instead. There were no adverse consequences or injury for the patient.
Patient Sequence No: 1, Text Type: D, B5
[50744395]
The device was evaluated and repaired by a third party repair facility.
Patient Sequence No: 1, Text Type: N, H10
[50744396]
The customer reported a temperature control issue with the fluid warmer. They further reported that the temperature that the machine was warming to was approximately 47 degrees celsius, which appeared to exceed that which was stated by the machine 42 degrees celsius. This was noticed by staff who where observing that the machine was running at a higher temperature than it was set to. The machine was immediately switched off and another machine from the fleet was used instead. There were no adverse consequences or injury for the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2016-00023 |
| MDR Report Key | 5407929 |
| Date Received | 2016-02-03 |
| Date of Report | 2016-01-07 |
| Date of Event | 2016-01-04 |
| Date Mfgr Received | 2016-01-07 |
| Device Manufacturer Date | 2012-05-07 |
| 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 |