MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-17 for CELSIOR CELSIOR COLD STORAGE SOLUTION CELSIOR CASE manufactured by Institut Georges Lopez Sas.
[97634236]
Dr. (b)(6) from (b)(6) called waters medical at approximately 10:30a, friday, (b)(6) 2017. Dr. (b)(6) stated that shands recorded three cases of right ventricle dysfunctions in which celsior was used. Two cases recovered after treatment and a third resulted in death. His concern was based on the fact that the ph of celsior was measured at the facility and found it to be approximately 6. 87 which was below the ifu stated ph of approximately 7. 3. The ph was performed on a blood gas ph meter on an unopened celsior package. Dr. (b)(6) stated that robert kelly (quality control - shands) would be the point person for all further communications. Product: celsior. Product lot: cel0061.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002123774-2017-00003 |
| MDR Report Key | 7201029 |
| Date Received | 2018-01-17 |
| Date of Report | 2017-08-04 |
| Date of Event | 2017-07-14 |
| Date Facility Aware | 2017-07-21 |
| Report Date | 2017-08-07 |
| Date Reported to FDA | 2017-08-07 |
| Date Reported to Mfgr | 2017-07-28 |
| Date Added to Maude | 2018-01-17 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 3 |
| Brand Name | CELSIOR |
| Generic Name | CELSIOR |
| Product Code | MSB |
| Date Received | 2018-01-17 |
| Model Number | CELSIOR COLD STORAGE SOLUTION |
| Catalog Number | CELSIOR CASE |
| Lot Number | CEL0061 |
| Device Expiration Date | 2018-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 13 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INSTITUT GEORGES LOPEZ SAS |
| Manufacturer Address | Z.A. LA CROIX GRAND BORNE SAINT-LAURENT-DE-CHAMOUSSET, 69930 FR 69930 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-01-17 |