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

Model Number 00620-CP

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Local Reaction (2035); Nasal Obstruction (2466); Swelling/ Edema (4577)

Event Date 12/29/2020

Event Type  Injury  

Manufacturer Narrative

The tubing harness is the only component of the plasma harness set that is eto sterilized.Haemonetics obtained device history record for the lot of the reported plasma harness set, sterilization parameters were within specification and within validated parameters.The sample was not available for return to hameonetics for evaluation.Without a physical sample the root cause cannot be determined.

Event Description

On december 30, 2020 haemonetics was notified of a donor reaction that fit the description of an ethylene oxide reaction which occurred on the process phase during a procedure, utilizing the pcs®2 plasma collection system and plasma harness set.The reaction occurred during saline infusion, the donor experienced periorbital swelling, nasal congestion and eye watering.

• Brand Name: PCS2 PLASMA COLLECTION SYSTEM
• Type of Device: 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: 11207571
• MDR Text Key: 227973897
• Report Number: 1219343-2020-00160
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 10812747011761
• UDI-Public: (01)10812747011761(17)230411(10)200412511
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK040025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2023
• Device Model Number: 00620-CP
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other