MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND S5 DOUBLE HEAD PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 10-85-00

Device Problems Device Inoperable (1663); Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem No Patient Involvement (2645)

Event Date 07/07/2015

Event Type  malfunction  

Manufacturer Narrative

The serial number was not provided.The manufacturing date cannot be determined.The information will be forwarded if available.Sorin group (b)(4) manufactures the s5 double head pump.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).The investigation is ongoing.A follow up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a report that the lock function of the double head pump was not functioning during maintenance/repair.There was no patient involvement.

Manufacturer Narrative

The initial report indicated that the serial number was unknown.This is incorrect; the serial number is (b)(4).Device manufacture date (mm/dd/yyyy): 10/31/2014.(b)(4) manufactures the s5 double head pump.The incident occurred in (b)(6).This medwatch report is filed on behalf of (b)(4).A (b)(4) field service representative was dispatched to the facility to investigate.The service representative was able to confirm the reported issue and traced the failure back to locking pin that had fallen off.The pin was reattached to resolve the issue.The device was tested without further malfunction and was returned to service.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Evaluated on site by (b)(4) technician.

• Brand Name: S5 DOUBLE HEAD PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindbergh strasse 25; munich D-809 39; GM D-80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 5001249
• MDR Text Key: 24798977
• Report Number: 9611109-2015-00271
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071318
• 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: Followup
• Report Date: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-85-00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2014
• 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