MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-16 for HEATER-COOLER UNIT manufactured by Unk.
[133553468]
A (b)(6) y/o with cad s/p cabg in 2008; mv repair on (b)(6) 2016 done at outside hospital (with annuloplasty and gortex valvuloplasty). Now diagnosed disseminated mycobacterium chimaera. Suspected contamination from heater-cooler unit during mv repair in 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083203 |
| MDR Report Key | 8257067 |
| Date Received | 2019-01-16 |
| Date of Report | 2019-01-11 |
| Date Added to Maude | 2019-01-17 |
| 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 |
| 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 | HEATER-COOLER UNIT |
| Generic Name | HEATER-COOLER UNIT |
| Product Code | ILO |
| Date Received | 2019-01-16 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention | 2019-01-16 |