MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-29 for VIASPAN manufactured by Bristol Myers Squibb.
[4614745]
During kidney transplant, after pt unclamped (organ perfused with recipient blood), blood pressure dropped and pt had an arrhythmia. Pt was coded and fully resuscitated at this time. Pt did very well with immediate function of her transplanted organ. Possible that the pt had a reaction to the preservation fluid, viaspan. Lot number was 16g10043 and the expiration date was september 2014. Diagnosis or reason for use: kidney preservation solution. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5036417 |
| MDR Report Key | 3845950 |
| Date Received | 2014-05-29 |
| Date of Report | 2014-05-27 |
| Date of Event | 2014-04-29 |
| Date Added to Maude | 2014-06-04 |
| 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 | 0 |
| Reporter Occupation | PHARMACIST |
| 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 | VIASPAN |
| Generic Name | PRESERVATION FLUID |
| Product Code | MSB |
| Date Received | 2014-05-29 |
| Lot Number | 16G10043 |
| ID Number | 01000004606 |
| Device Expiration Date | 2014-09-01 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRISTOL MYERS SQUIBB |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2014-05-29 |