MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-15 for B/F WARM SET HIGH FLOW CE D25330CE manufactured by Stryker Medical-kalamazoo.
[34136896]
It was reported by the customer that air was in the distal part of the iv line coming from the (b)(4). The customer also alleged that no leaks were noted at the beginning of the procedure and claims that the leaks were noticed after the medication was injected in the line at the top of the iv. It was also noted by the customer that no infusion devise was used in this case. The hospital anaesthetic technician coordinator has confirmed that the procedure only involved the bag of fluid, the iv giving set, and the stryker cassette with fluid warmer. The patient was not injured during the event.
Patient Sequence No: 1, Text Type: D, B5
[44743850]
The device was not returned for evaluation. The device was not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[44743851]
It was reported by the customer that air was in the distal part of the iv line coming from the fw603. The customer also alleged that no leaks were noted at the beginning of the procedure and claims that the leaks were noticed after the medication was injected in the line at the top of the iv. It was also noted by the customer that no infusion devise was used in this case. The hospital anaesthetic technician coordinator has confirmed that the procedure only involved the bag of fluid, the iv giving set, and the stryker cassette with fluid warmer. The patient was not injured during the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2015-00633 |
| MDR Report Key | 5298601 |
| Date Received | 2015-12-15 |
| Date of Report | 2015-12-03 |
| Date of Event | 2015-11-28 |
| Date Mfgr Received | 2015-12-03 |
| Date Added to Maude | 2015-12-15 |
| 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 | 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 | B/F WARM SET HIGH FLOW CE |
| Generic Name | DEVICE, WARMING. BLOOD AND PLASMA |
| Product Code | KZL |
| Date Received | 2015-12-15 |
| Catalog Number | D25330CE |
| 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 | 2015-12-15 |