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

Report number on initial report was 9611109-2015-00397; the correct report number is 9611109-2015-00455.

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 deutschland 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.

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 pt involvement.The investigation is ongoing.A f/u 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 pt involvement.

Manufacturer Narrative

It was discovered on march 1, 2016, that the initial report for this event was never received by the fda.This was the result of a submission failure on the date of initial filing (october 9, 2015) caused due to a "duplicate report" error.Reports 9611109-2015-00397 and 9611109-2015-00455 were accidentally both submitted as 9611109-2015-00397.Because it is not readily apparent to the user that a report has failed submission (no emails or notifications are sent out and each acknowledgement has to be opened and searched for a failure), it was not discovered until march 1, 2016 during a retrospective review that the initial report was never received by the fda.Before the company became aware of this submission issue, it submitted multiple supplemental reports (follow-up #1 sent on october 12, 2015 to correct incorrect report number, not knowing that initial was never received, and follow-up #2 sent on january 5, 2016).For clarity, the company is submitting this mdr as an initial report that includes all currently known information about this event.Therefore, the prior filed supplements are obsolete.There was no patient involvement.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.A review of the dhr could not identify any concessions, deviations or nonconformities relevant to the reported failure.This issue is known to sorin group (b)(4) and they have initiated capa (b)(4) to develop corrective actions for the condition.Sorin group (b)(4) has also implemented change order (b)(4) as a correction to change the mold.

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.

• 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: 5145367
• MDR Text Key: 50253047
• Report Number: 9611109-2015-00455
• 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: Initial,Followup,Followup,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
• Initial Date Manufacturer Received: 09/10/2015
• Initial Date FDA Received: 10/13/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 10/13/2015; 01/05/2016; 03/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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