MAUDE Adverse Event Report: HAEMONETICS CORPORATION PCS2 PLASMA COLLECTION SYSTEM; PLS HARNESS SET CP

Model Number	00620-CP
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Three units were received for evaluation.The units were evaluated to check for any defects.The units were all submersion leak tested and no leaks were identified.A visual evaluation was conducted on all three tubing harnesses and units were missing bag spikes, pumps stops and/or bowl connectors.The evaluation is still in progress, information will be updated once completed.
Event or Problem Description
On may 04, 2021 haemonetics was notified of a blad error resulting in blood loss, utilizing a plasma harness set.During the procedure it was reported that excessive bubbling was observed in filter causing excessive air between bowl and donor.There was also a report of red blood cell loss of greater than 200ml.The donor was disconnected immediately and there was no record of patients healths being impacted.

• Brand Name: PCS2 PLASMA COLLECTION SYSTEM
• Common Device Name: PLS HARNESS SET CP
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• MDR Report Key: 11935125
• Report Number: 1219343-2021-00026
• Device Sequence Number: 4662396
• Product Code: GKT
• UDI-Device Identifier: 10812747011761
• UDI-Public: (01)10812747011761(17)230712(10)200713511
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: company representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/04/2021

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-CP
• Device Lot Number: 200713511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1