MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08,distributor report with the FDA on 2015-07-10 for B/F WARM SET HIGH FLOW CE D25330CE manufactured by Stryker Medical-kalamazoo.
[18658964]
It was alleged that the meditemp fluid warmer cassette ruptured during use. It was alleged the cassette was primed in the usual manner with normal saline and then used to infuse blood into the patient as per hospital protocol. The cassette rupture occurred whilst the hospital staff were infusing blood into a patient. It was alleged the surgical procedures were delayed/prolonged due to the theatre staff having to locate another meditemp blood warmer and cassette and set up a new blood infusion for patient. It was alleged that prolonged recovery time for patient post operatively, due to delivery of blood at less optimal temperature.
Patient Sequence No: 1, Text Type: D, B5
[25505230]
The investigation concluded that a likely cause for this issue is using a pump in series with the device creating a greater than specified pressure which contributed to the cassette leak.
Patient Sequence No: 1, Text Type: N, H10
[25505231]
It was alleged that the meditemp fluid warmer cassette ruptured during use. It was alleged the cassette was primed in the usual manner with normal saline and then used to infuse blood into the patient as per hospital protocol. The cassette rupture occurred whilst the hospital staff were infusing blood into a patient. It was alleged the surgcial procedures were delayed/prolonged due to the theatre staff having to locate another meditemp blood warmer and cassette and set up a new blood infusion for patient. It was alleged that prolonged recovery time for patient post operatively, due to delivery of blood at less optimal temperature.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2015-00338 |
| MDR Report Key | 4906932 |
| Report Source | 08,DISTRIBUTOR |
| Date Received | 2015-07-10 |
| Date of Report | 2015-07-06 |
| Date of Event | 2015-07-02 |
| Date Mfgr Received | 2015-07-06 |
| Date Added to Maude | 2015-08-04 |
| 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 | 2015-07-10 |
| Catalog Number | D25330CE |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-07-10 |