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S5 Double Roller Pump 85 recallZ-1326-2012 · Sorin Group Deutschland GmbH · initiated Feb 23, 2012

Terminated All recalls posted in March 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Sorin Group Deutschland GmbH or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The pump speed control knob is attached to the shaft of an encoder that is used to adjust the speed. Insufficient lubrication within the encoder increases friction over time making it more difficult to turn the pump speed control knob. Excessive friction causes premature wear of the encoder shaft which can result in a stuck shaft.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Sorin Group sent an Urgent Field Safety Notice dated February 23, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: Before each use of the device during the set-up procedure, rotate all pump speed control knobs back and forth to check for smooth operation. If abnormal friction or any binding is detected, please do not use the system until it is repaired. If an affected product is currently in use with a patient and an increase of friction is detected please prepare for a replacement pump. Please complete and return the attached Confirmation Form by fax to 303-467-6502. Customers were instructed to ensure that the Urgent Field Safety Notice is distributed to all personnel in their organization who need to be aware of the notice. If the product was transferred to a third party, customers were asked to share the information with them as well as Sorin Group USA Customer Service at 1-800-850-2623. For questions regarding this Urgent Field Safety Notice, contact Sorin Group USA Customers Service at 1-800-650-2623. All affected customers and distributors were notified of the Field Correction by certified mail beginning on February 23, 2012. They will be contacted by Sorin Service Group to arrange an appointment to replace affected shaft encoders on site.

Recall details

Recall number
Z-1326-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Feb 23, 2012
Posted by the FDA
Mar 29, 2012
Recalling firm
Sorin Group Deutschland GmbH
Quantity
251
Product code
DTQ
FDA submissions
K071318
Distribution
Worldwide Distribution

Product description

S5 Double Roller Pump 85 The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours.

Code information (models, lots, serial numbers)

10E51342 to 10E51597

Other devices under the same FDA submission

22 devices cleared under K071318 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 61375).

Sources and updates

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