MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND GMBH S5 ROLLER PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE

Model Number 10-80-00

Device Problem No Display/Image (1183)

Patient Problem No Patient Involvement (2645)

Event Date 11/01/2015

Event Type  malfunction  

Manufacturer Narrative

Device has not been returned to sorin group (b)(4).Sorin group (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group(b)(4).Sorin group (b)(4) gmbh received a report that the display of the s5 roller pump became fuzzy and turned off during priming.There was no patient involvement.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) gmbh received a report that the display of the s5 roller pump became fuzzy and turned off during priming.There was no patient involvement.

Manufacturer Narrative

Sorin group (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the display of the s5 roller pump became fuzzy and turned off during priming.There was no patient involvement.A service representative from a distributor was dispatched to the facility to investigate.The service representative reproduced the reported failure and replaced the touch screen and processor board to resolve the fault.The replaced parts were returned to sorin group (b)(4) for further investigation.Visual inspection and functional testing of the returned touch screen found no issues.During functional testing and hardware analysis of the processor board, the reported failure was reproduced.Visual inspection of the board identified bad soldering joints on one of the components.The component was resoldered and subsequent testing did not identify further issues.The returned devices were scrapped as a precaution.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.No trend was identified for this type of issue.The responsible production department was informed of the failure and sorin group (b)(4) will continue to monitor for trends related to this type of issue.

• Brand Name: S5 ROLLER PUMP
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND GMBH; 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: 5336883
• MDR Text Key: 34745056
• Report Number: 9611109-2015-00604
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/19/2015

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 Model Number: 10-80-00
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2015
• Initial Date FDA Received: 12/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2014
• 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