MAUDE Adverse Event Report: SORIN GROUP ITALIA APPARATUS, AUTOTRANSFUSION; XTRA AUTOTRANSFUSION SYSTEM

Catalog Number 04257

Device Problems Leak/Splash (1354); Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2015

Event Type  Other  

Manufacturer Narrative

Pt info was not provided.The lot number was not provided.The expiration date unk.The info will be forwarded when available.Mfg date.The lot number was not provided.Therefore the manufacturing date is unk.It will be forwarded when available.Sorin group (b)(4) manufactures the xtra autotransfusion procedure set.The incident occurred in (b)(6).This medwatch is being filed on behalf of sorin group (b)(4).Sorin group received a report that pump boot of the autotransfusion set leaked during the procedure.No medical intervention or blood products were given as result of the leak.There was no report of pt 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 the pump boot of the autotransfusion set leaked during the procedure.No medical intervention or blood products were given as a result of the leak.There was no report of pt injury.

Manufacturer Narrative

(b)(4).Sorin group (b)(4) manufactures the xtra autotransfusion procedure set.The incident occurred in el (b)(6).(b)(4).The customer provided a photograph of the involved device to sorin group (b)(4) for investigation.Analysis of the photo confirmed a leak from a rupture in the pump loop of the xtra set.Based on similar cases investigated in the past, the issue was likely caused either by an incorrect length of the pump loop or by an incorrect automatic loading of the pump loop into the xtra equipment.As the device was not available for investigation, it is not possible to determine the exact origin of the rupture.As the lot of the xtra set was not provided, a review of the device history record could not be performed.As the defect rate for this type of issue is remote, no corrective action is necessary.However, sorin group (b)(4) will continue to monitor for trends related to this type of issue.

• Brand Name: APPARATUS, AUTOTRANSFUSION
• Type of Device: XTRA AUTOTRANSFUSION SYSTEM
• Manufacturer (Section D): SORIN GROUP ITALIA; via statale 12 nord, 86; mirandola ; IT
• Manufacturer (Section G): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola (modena), 41037 ; IT 41037
• Manufacturer Contact: joan ceasar ; 14401 w 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 5074994
• MDR Text Key: 26005235
• Report Number: 9680841-2015-00345
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101586
• 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: Followup
• Report Date: 02/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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