MAUDE Adverse Event Report: HAEMONETICS, INC. MCS+9000 WITH PLASMA SET W/FILTERS, BMB

Model Number 0792P-SL

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2021

Event Type  malfunction  

Manufacturer Narrative

Product was not returned, therefore, haemonetics is unable to perform an investigation and a cause can not be established.There was no reported patient harm associated with this event.

Event Description

On (b)(6) 2021, haemonetics was notified of a non-compliance in residual white blood cells during sampling plan after plasma collection (14490/l) utilizing the mcs+9000 mobile collection system and plasma set.There was no report of donor harm.

Manufacturer Narrative

Supplemental report 1219343-2022-00002-01 is notification that mdr 1219343-2022-00002 was submitted in error and no future reports involving this part will be filed.It was discovered during the haemonetics investigation that the filter used by this customer is part of a disposable kit that is sold only in france.This filter and any similar products to it are not sold/distributed by haemonetics in any other market, including the united states.This specific plasma collection resulted in a loss of product, therefore, would not impact donor/user safety.

• Brand Name: MCS+9000 WITH PLASMA SET W/FILTERS, BMB
• Type of Device: MCS+9000 WITH PLASMA SET W/FILTERS, BMB
• Manufacturer (Section D): HAEMONETICS, INC.; 125 summer street; boston MA 02110
• Manufacturer (Section G): HAEMONETICS, INC.; 125 summer street; boston MA 02110
• Manufacturer Contact: brenda bruyere ; 125 summer street; boston, MA 02110
• MDR Report Key: 13237224
• MDR Text Key: 291295176
• Report Number: 1219343-2022-00002
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: BK010035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 12/28/2021

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: 0792P-SL
• Device Lot Number: 892118
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/28/2021
• Initial Date FDA Received: 01/12/2022
• Supplement Dates Manufacturer Received: 12/28/2021
• Supplement Dates FDA Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1