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

Model Number 10-85-00

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2014

Event Type  malfunction  

Event Description

Sorin group (b)(4) received a report that, during a procedure, an object was dropped onto the touch screen of the s5 double head pump whereby cracking the display and making the pump inoperable.There was no report of patient injury.

Manufacturer Narrative

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.

Manufacturer Narrative

Sorin group (b)(4) manufactures the s5 double head pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that, during a procedure, an object was dropped onto the touch screen of the s5 double head pump whereby cracking the display and making the pump inoperable.There was no report of patient injury.The device was not returned to sorin group deutschland for evaluation, but a photograph from the customer showing the cracked touch screen was received.Inspection of the received photo confirmed the reported issue and concluded that the damage is consistent with an object being dropped on the touch screen.A review of the dhr could not identify any concessions, deviations or nonconformities relevant to the reported failure.This issue will be monitored for trends and if a trend is identified, corrective action will be recommended.This report was originally submitted on december 7, 2015 with the incorrect mfr report number (was filed as 9611109-2015-00498), however the submission name was correctly captured as 1718850-2014-00498.Sorin group will resubmit this mdr on january 8th to correct the mfr report number.

• Brand Name: S5 DOUBLE HEAD PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr 25; munich 80939 ; GM 80939
• 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: 4388016
• MDR Text Key: 5304781
• Report Number: 1718850-2014-00498
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Unknown
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2014
• 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: 11/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2010
• 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