MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-14 for CRYOGENIC STORAGE BAG manufactured by Origen Biomedical Inc..
[136994683]
During infusion of stem cell transplant the 9th and final bag of cells was perforated during spiking; no cells were lost at that time. The second rn applied hemostat to area of tear and it was placed too low and approx. 10cc of cells were lost when the bag was flipped over to hang. Two more hemostats were placed and the remaining cells were infused without difficulty.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084094 |
| MDR Report Key | 8343369 |
| Date Received | 2019-02-14 |
| Date of Report | 2019-02-06 |
| Date of Event | 2018-12-19 |
| Date Added to Maude | 2019-02-15 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CRYOGENIC STORAGE BAG |
| Generic Name | CONTAINER, FROZEN DONAL TISSUE STORAGE |
| Product Code | LPZ |
| Date Received | 2019-02-14 |
| Lot Number | T50281-3N |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORIGEN BIOMEDICAL INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-14 |