MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-10-02 for XTRA N/A 04251 manufactured by Sorin Group Italia.
[27419405]
Patient information was not provided. Sorin group (b)(4) manufactures the xtra disposable. The incident occurred in (b)(6). This medwatch report is being filed on behalf of sorin group (b)(4). Sorin group received a report that samples taken from blood processed using an xtra autotransfusion device showed hemolysis. It was also reported that the patient experienced hypotension but there was no injury. A report against the equipment was filed under medwatch number 9611109-2015-00346. The investigation is ongoing. A follow-up report will be sent when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[27419406]
Sorin group received a report that samples taken from blood processed using an xtra autotransfusion device showed hemolysis. It was also reported that the patient experienced hypotension but there was no injury.
Patient Sequence No: 1, Text Type: D, B5
[35325425]
Sorin group (b)(4) manufactures the xtra disposable. The incident occurred in (b)(6). This medwatch report is being filed on behalf of sorin group (b)(4). Sorin group received a report that samples taken from blood processed using an xtra autotransfusion device showed hemolysis. It was also reported that the patient experienced hypotension but there was no injury. A report against the equipment was filed under medwatch number 9611109-2015-00346. The device was not returned to sorin group for investigation, but an investigation was performed by the customer. Follow-up communication with the customer has revealed that the reported issue was unrelated to the xtra autotransfusion device and the disposable. A pathologist analyzed the cell saver blood and was able to rule out any issues with the blood. After a full investigation, the facility concluded that the issue experienced by the patient was not related to cell salvage. The patient was on angiotensin-converting enzyme (ace) inhibitors at the time of the event, which are widely used as treatment for hypertension. Hypotension is a potential side effect of the use of these drugs. A review of the dhr was unable to identify any concessions, deviations or non-conformities relevant to the reported failure. No trends was identified for this type of issue; this is the first report of potential correlation between hypotension and the use of the xtra machine and disposables. Sorin group (b)(4) will continue to monitor the market for trends related to this issue. Investigation performed by customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680841-2015-00413 |
| MDR Report Key | 5125236 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-10-02 |
| Date of Report | 2015-09-04 |
| Date of Event | 2015-07-16 |
| Date Mfgr Received | 2015-12-15 |
| Device Manufacturer Date | 2015-03-01 |
| Date Added to Maude | 2015-10-02 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CARRIE WOOD |
| Manufacturer Street | 14401 W 65TH WAY |
| Manufacturer City | ARVADA CO 80004 |
| Manufacturer Country | US |
| Manufacturer Postal | 80004 |
| Manufacturer Phone | 3034676461 |
| Manufacturer G1 | SORIN GROUP ITALIA |
| Manufacturer Street | VIA STATALE 12 NORD, 86 |
| Manufacturer City | MIRANDOLA, 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 |
| Generic Name | AUTOTRANSFUSION SYSTEMS |
| Product Code | DTN |
| Date Received | 2015-10-02 |
| Model Number | N/A |
| Catalog Number | 04251 |
| Lot Number | 1503170114 |
| Device Expiration Date | 2018-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SORIN GROUP ITALIA |
| Manufacturer Address | VIA STATALE 12 NORD, 86 MIRANDOLA (MO), 41037 IT 41037 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-02 |