MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-28 for SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM 050228 manufactured by Sorin Group Italia Srl.
[136740372]
Patient information was not provided. The bcd vanguard (item 050229, lot number unknown) is a non-sterile device that was assembled into convenience pack (catalog number unknown) that is not distributed in the usa. The lot and the expiry date (mm/dd/yyyy) of the complained convenience pack are not known. As the sterile convenience pack is not distributed in usa, the udi number is not applicable. Age of the device: as the lot is unknown, sterilization date could not be determined and the age of the device could not be calculated. (b)(4). The sorin biomedica smarxt bcd vanguard is a non-sterile component assembled into a convenience pack that is not distributed in the usa. The non-sterile cardioplegia heat exchanger is also distributed in the usa (510(k)number: k934847). Device manufacture date (mm/dd/yyyy) of the convenience pack: as the lot number is unknown, the manufacture date could not be determined. Sorin group (b)(4) manufactures the sorin biomedica smarxt bcd vanguard. The hospital where the incident occurred was (b)(6). Sorin group (b)(4) was informed by the distributor (b)(4). (b)(4). The involved device has been requested for return to sorin group (b)(4) for investigation. If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report. Device not yet returned.
Patient Sequence No: 1, Text Type: N, H10
[136740373]
Sorin group (b)(4) has received a report that, after infusion of cardioplegic solution, during the cardioplegia standby, air was detected in the upper part of the bcd vanguard. There is no report of any patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680841-2019-00002 |
| MDR Report Key | 8281012 |
| Date Received | 2019-01-28 |
| Date of Report | 2019-04-26 |
| Date of Event | 2018-12-03 |
| Date Facility Aware | 2018-12-21 |
| Date Mfgr Received | 2019-03-29 |
| Date Added to Maude | 2019-01-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | NJEMILE CRAWLEY |
| Manufacturer Street | 14401 W 65TH WAY |
| Manufacturer City | ARVADA CO 80004 |
| Manufacturer Country | US |
| Manufacturer Postal | 80004 |
| Manufacturer Phone | 2812287575 |
| Manufacturer G1 | SORIN GROUP ITALIA SRL |
| Manufacturer Street | STRADA STATALE 12 NORD, 86 |
| Manufacturer City | MIRANDOLA, MODENA 41037 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 41037 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM |
| Generic Name | CARDIOPLEGIA HEAT EXCHANGER |
| Product Code | DTR |
| Date Received | 2019-01-28 |
| Returned To Mfg | 2019-02-05 |
| Catalog Number | 050228 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SORIN GROUP ITALIA SRL |
| Manufacturer Address | STRADA STATALE 12 NORD, 86 MIRANDOLA, MODENA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-28 |