MAUDE Adverse Event Report: HAEMONETICS CORPORATION PCS®2 PLASMA COLLECTION SYSTEM; PLS HARNESS SET CP

Model Number	00620-00
Medical Device Problem Code	Inadequate Filtration Process (2308)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Donor information is unavailable, there was also no indication of harm to the donor.Haemonetics is reporting as a precautionary measure due to the particulate was alleged to pass the filter, as the filter is a mitigation to prevent particulates.The investigation and identification malfunction has occurred is pending.
Event or Problem Description
On (b)(6), 2021 haemonetics was notified of particles detected in the donor tubing which occurred during the removal/disassembly of the disposables in (b)(6), utilizing a plasma harness set.
Additional Manufacturer Narrative
Based on the process and preserved sample review, there was no abnormality observed that may have resulted in this defect.Furthermore, based on sample received, no foreign particles were observed after filtering the liquid used for decontamination.Hence, haemonetics suspects that the foreign particle is dried blood (protein) and unlikely caused by the manufacturing process.

• Brand Name: PCS®2 PLASMA COLLECTION SYSTEM
• Common Device Name: PLS HARNESS SET CP
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer Contact: janice kiser ; 125 summer street; boston, MA 02110
• MDR Report Key: 12541127
• Report Number: 1219343-2021-00127
• Device Sequence Number: 1416170
• Product Code: GKT
• UDI-Device Identifier: 10812747011754
• UDI-Public: (01)10812747011754(17)240309(10)210310522
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: BK040025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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 Model Number: 00620-00
• Device Lot Number: 210310522
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown