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

Model Number 10-80-00

Device Problem Device Issue (2379)

Patient Problem No Patient Involvement (2645)

Event Date 09/05/2015

Event Type  malfunction  

Manufacturer Narrative

Sorin group (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group received a report that the magnet was missing from the pump cover of the s5 roller pump.This was discovered during set-up, so 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 received a report that the magnet was missing from the pump cover of the s5 roller pump.This was discovered during set-up, so 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 being filed on behalf of sorin group (b)(4).Sorin group received a report that the magnet was missing from the pump cover of the s5 roller pump.This was discovered during set-up, so there was no patient involvement.To resolve the issue, a replacement pump cover has been provided to the customer.No product was returned to sorin group (b)(4) for investigation.This issue is a known issue and is addressed by capa (b)(4).A review of the dhr could not identify any concessions, deviations or nonconformities relevant to the reported failure.A capa (b)(4 has been opened to address this issue and change order (b)(4) to change the mold has already been implemented as a correction.

• Brand Name: S5 ROLLER 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: 5142585
• MDR Text Key: 28040312
• Report Number: 9611109-2015-00397
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: Followup
• Report Date: 09/10/2015

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/10/2014
• 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