MAUDE Adverse Event Report: SORIN GROUP ITALIA 745E225 KIT ATS X ELECTA; APPARATUS, AUTOTRANSFUSION

Catalog Number 01470M

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem Other (for use when an appropriate patient code cannot be identified) (2200)

Event Type  Other  

Event Description

Sorin group (b)(6) received a report that, after being given blood which was processed using the electa autotransfusion system, the patient developed renal insufficiency resulting in hemoglobinuria, anuria, acute kidney injury and hyperkalemia.After 48 hours of continuous observation, the patient was released with no permanent injury.

Manufacturer Narrative

Patient identifier and weight were not provided.Sorin group (b)(6) manufactures the (b)(4) kit ats x electa.This kit is not sold in the united states but is similar to another kit (catalog # 04165m) which is distributed in the united states, under 510(k) number (b)(4).The incident occurred in (b)(6).This medwatch is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that, after being given blood which was processed using the electra autotransfusion system, the patient developed renal insufficiency resulting in hemoglobinuria, anuria, acute kidney injury and hyperkalemia.After 48 hours of continuous observation, the patient was released with no permanent injury.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

• Brand Name: 745E225 KIT ATS X ELECTA
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): SORIN GROUP ITALIA; via statale 12 norde, 86; mirandola ; IT
• Manufacturer (Section G): SORIN GROUP ITALIA; via statale 12 nord, 86; mirandola ; IT
• Manufacturer Contact: cheri voorhees, manager ; 14401 west 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 4379347
• MDR Text Key: 5116420
• Report Number: 1718850-2014-00485
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Unknown
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 01470M
• Device Lot Number: 1407160016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2014
• Initial Date FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21 YR