MAUDE Adverse Event Report: HAEMONETICS CORP MCS®+ 9000 SYSTEM; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC

Model Number 09000-220-ED

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/19/2016

Event Type  malfunction  

Manufacturer Narrative

A haemonetics field service engineer visited the reporting facility.Two full cycles were performed and the reported issue was not able to be replicated.Haemonetics has not concluded the investigation into this reported event.A supplemental report will be filed when the investigation is complete.

Event Description

Haemonetics received a complaint on (b)(6) 2016 stating that during the priming step, the tubing was not loaded in the ac pump, but the customer complained that no alarm was displayed during the priming process.Two cycles were completed before the user realized the issue.Further clarification with the customer determined that the manifold of the disposable set was not fully clamped down into place by the operator of the device which did not allow for auto loading of the tubing.This resulted in over-consumption of anticoagulant solution.There was no donor adverse event.The customer continued to use the device for subsequent donations with no reported issues.

Manufacturer Narrative

A haemonetics field service engineer evaluated the device.In addition, several independent haemonetics employees attempted to replicate the error.The defect was attempted to be replicated on an mcs+9000 machine utilizing ppp&ffp-c-fr protocol, however could not go past a high pressure error (code 257) during prime when the ac tubing was not threaded within the ac pump.In each case, the individual could not get past the initial device set-up due to the "high pressure" alarm which could not be cleared to proceed to draw.The root cause cannot be established as the reported issue could not be replicated.The machine was not taken out of service and further procedures were performed without issues.There were no device anomalies found from manufacturing that may have contributed to the reported issue.Design history records show the device met specifications at final manufacturing tests and the machine was released.

• Brand Name: MCS®+ 9000 SYSTEM
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): HAEMONETICS CORP; 400 wood rd; braintree MA 02184
• Manufacturer (Section G): HAEMONETICS CORP; 400 wood rd; braintree MA 02184
• Manufacturer Contact: julie smith, rn ; 400 wood rd; braintree, MA 02184 ; 7819170643
• MDR Report Key: 5857673
• MDR Text Key: 52780951
• Report Number: 1219343-2016-00057
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: BK080038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/12/2016

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: 09000-220-ED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2016
• Initial Date FDA Received: 08/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2001
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1