MAUDE Adverse Event Report: HAEMONETICS CORPORATION 2 UNIT RED CELL SET W/RC2H FIL

Model Number	0832F-00
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2021, haemonetics manufacturing performed a visual inspection of the returned sample and it was confirmed that the configuration of the unit is correct (all components are correctly assembled).Kinks were found throughout the all tubing however, since the returned sample was received with the tubing's coiled, it is not possible to confirm if these kinks were generated due to the way the sample was returned or for other reason.A visual evaluation was conducted and it was found that the 6 filter holes are not blocked.Both sides of the filter were checked and there are no traces of solvent on either side.The media is damaged with one hole close to the outlet.
Event or Problem Description
On (b)(6) 2021, haemonetics was notified of weight changing too slowly in rbc transfer, weight changing to slowly in plasma return, air detected at blad alarms during return and possible rbc spill during draw alarms utilizing a 2 unit red cell set.

• Brand Name: 2 UNIT RED CELL SET W/RC2H FIL
• Common Device Name: 2 UNIT RED CELL SET W/RC2H FIL
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• MDR Report Key: 12711245
• Report Number: 1219343-2021-00136
• Device Sequence Number: 13813627
• Product Code: GKT
• UDI-Device Identifier: 10812747013512
• UDI-Public: (01)10812747013512(17)240303(10)0321042
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: BK060023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/03/2024
• Device Model Number: 0832F-00
• Device Lot Number: 0321042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1