MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-10-30 for THERMO FISHER SCIENTIFIC BPL25 manufactured by Thermo Fisher Scientific, Headquarters.
[967119]
Recurring problems with blood bank refrigerator door handles. Door handles (lock & strike assembly) are having to be replaced on a quarterly basis. The door handles appear to be of poor design and made with inferior materials that lead to their constant breakage. Prior to their complete failure, the handles also cause problems with the closure of the refrigerators' doors. When this occurs, the refrigerators exhibit increased storage temps and temp alarms related to the door not closing properly and sealing, and lead potentially to the loss of blood products by way of the increased (excessive) storage temps. We feel that if the door handle was of better design and made of better (e. G. , stronger, more durable) materials, this problems would not occur as often as it is now.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5008817 |
| MDR Report Key | 1216534 |
| Date Received | 2008-10-30 |
| Date of Report | 2008-10-24 |
| Date of Event | 2008-10-21 |
| Date Added to Maude | 2008-11-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERMO FISHER SCIENTIFIC |
| Generic Name | BLOOD BANK REFRIGERATOR |
| Product Code | KSE |
| Date Received | 2008-10-30 |
| Model Number | BPL25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1266818 |
| Manufacturer | THERMO FISHER SCIENTIFIC, HEADQUARTERS |
| Manufacturer Address | 81 WYMAN ST WALTHAM MA 02454 US |
| Brand Name | THERMO FISHER SCIENTIFIC |
| Generic Name | BLOOD BANK REFRIGERATOR |
| Product Code | KSE |
| Date Received | 2008-10-30 |
| Model Number | BBR25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 2 |
| Device Event Key | 1266819 |
| Manufacturer | THERMO FISHER SCIENTIFIC, HEADQUARTERS |
| Manufacturer Address | 81 WYMAN ST WALTHAM MA 02454 US |
| Brand Name | THERMO FISHER SCIENTIFIC |
| Generic Name | BLOOD BANK REFRIGERATOR |
| Product Code | KSE |
| Date Received | 2008-10-30 |
| Model Number | BBR55 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 3 |
| Device Event Key | 1266820 |
| Manufacturer | THERMO FISHER SCIENTIFIC, HEADQUARTERS |
| Manufacturer Address | 81 WYMAN ST WALTHAM MA 02454 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-10-30 |