MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND XTRA EQUIPMENT 110V, 60HZ; APPARATUS, AUTOTRANSFUSION

Model Number 75221

Device Problems Other (for use when an appropriate device code cannot be identified) (2203); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2015

Event Type  Other  

Manufacturer Narrative

Sorin group (b)(4) manufactures the xtra equipment.The incident occurred in (b)(6).This medwatch report is filled 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 patient injury.There was no report of patient injury.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group received a report that samples taken from blood processed using an xtra autotransfusion devices showed hemolysis.It was reported that the patient experienced hypotension but there was no patient injury.

Manufacturer Narrative

"date of event" on initial report should have been (b)(6) 2015."date of this report" on initial report should have been (b)(6) 2015."date received by manufacturer" on initial report should have been (b)(6) 2015.

Manufacturer Narrative

Sorin group (b)(4) manufactures the xtra equipment.The incident occurred in (b)(6).This medwatch report is 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 disposable was filed under medwatch number 9680841-2015-00415.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 savor 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.No further investigation is required as there is no indication that this issue was related to cell salvage.A review of the dhr was unable to identify any concessions, deviations or non-conformities relevant to the reported failure.No trend was identified for this type of issue.Sorin group (b)(4) will continue to monitor the market for trends related to this issue.

• Brand Name: XTRA EQUIPMENT 110V, 60HZ
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND ; lindberghstr. 25; munich D8093 9; GM D80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5060855
• MDR Text Key: 39997498
• Report Number: 9611109-2015-00347
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 75221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/11/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1