MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-11-15 for XTRA AUTOTRANSFUSION SYSTEM, PROCEDURE SET TX/125 04255J manufactured by Sorin Group Italia S.r.l..
[129032265]
The complained xtra autotransfusion system procedure set tx/125 (catalog number 04255j, lot 1806110152) is not distributed in the usa, therefore the udi is not applicable. The procedure set tx/125 is similar to the procedure set tx/125 item 04255, which is distributed in the usa, for which the device identifier is (b)(4). The age of the device was calculated as the time elapsed between device sterilization and the date of the event. (b)(4). Catalog number 04255j is not distributed in the usa, but it is similar to the procedure set tx/125 (catalog number 04255), which is distributed in the usa (510(k) number: k101586). The device manufacture date refers to manufacture date of the sterile, finished set. Sorin group (b)(4) manufactures the xtra procedure set tx/125. The incident occurred in (b)(6). (b)(4). The involved device has been requested for return to sorin group (b)(4) for investigation. The device has not yet been received. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report. Device not yet returned.
Patient Sequence No: 1, Text Type: N, H10
[129032266]
Sorin group (b)(4) received a report that blood sprayed onto 2 medical engineers during patient blood processing utilizing a xtra procedure set (tx/125). There was no report of any injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680841-2018-00029 |
| MDR Report Key | 8072848 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-11-15 |
| Date of Report | 2019-01-18 |
| Date of Event | 2018-10-17 |
| Date Facility Aware | 2018-10-17 |
| Date Mfgr Received | 2018-12-21 |
| Device Manufacturer Date | 2018-06-11 |
| Date Added to Maude | 2018-11-15 |
| 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 | ENRICO MILANI |
| Manufacturer Street | 14401 W 65TH WAY |
| Manufacturer City | ARVADA CO 80004 |
| Manufacturer Country | US |
| Manufacturer Postal | 80004 |
| Manufacturer Phone | 2812287260 |
| 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 | 3 |
| Brand Name | XTRA AUTOTRANSFUSION SYSTEM, PROCEDURE SET TX/125 |
| Generic Name | APPARATUS, AUTOTRANSFUSION |
| Product Code | CAC |
| Date Received | 2018-11-15 |
| Returned To Mfg | 2018-11-19 |
| Catalog Number | 04255J |
| Lot Number | 1806110152 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SORIN GROUP ITALIA S.R.L. |
| Manufacturer Address | STRADA STATALE 12 NORD, 86 MIRANDOLA, MODENA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-15 |