MAUDE Adverse Event Report: HAEMONETICS PCS®2 PLASMA COLLECTION SYSTEM; PCS2,LIST NO,06002-110-EXP-EW

Model Number 06002-110-EXP-EW

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Lethargy (2560)

Event Date 05/02/2022

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2022, a haemonetics field service engineer evaluated the device used by the donor.Diagnostics, functional test and visual inspections were performed and all systems passed.The device was found to have met manufacturer specifications with no malfunction found.The investigation shows there are no non-conformances against the device serial number used in the donation procedure and no corrective/preventive actions related to this complaint.A review of the device history record showed no issues during the manufacture of this device and all testing passed.The device was manufactured according to approved procedures and met all specifications for release, with no noted manufacturing deviations.A review of the service record for this device shows no similar complaints.There were no machine errors or issues with the disposables used during the donation procedure reported in the complaint.The pcs®2 plasma collection system collects blood product from a donor, then processes it through the system to separate plasma which is then expressed into a collection container.It is not possible to extract plasma directly from a donor as stated in the complaint.There is no evidence to suggest that the donor reaction was related to the device used during the plasmapheresis procedure.

Event Description

Letter received from donor's representative on (b)(6) 2022 alleging: (i) donor was injured while attending a donation procedure at the center, (ii) the device failed to alert the technician that it was primarily drawing plasma from the donor.The technician noticed the discrepancy in the tubing coloring, which was allegedly filled with transparent plasma from donor and not blood and plasma.Allegedly this procedure went on for quite some time to the point where uncharacteristic lethargy was present and donor wanted to do nothing but sleep.Donor was removed from device and given energy replenishing libations.Donor was advised not to return to donate for 90 days for the blood cells to revive.After this occurrence, donor was rushed to the hospital for chronic lethargy and was diagnosed as being severely anemic.

• Brand Name: PCS®2 PLASMA COLLECTION SYSTEM
• Type of Device: PCS2,LIST NO,06002-110-EXP-EW
• Manufacturer (Section D): HAEMONETICS; 125 summer street; boston MA 02110
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer Contact: brenda bruyere ; 125 summer street; boston, MA 02110
• MDR Report Key: 15824522
• MDR Text Key: 303902795
• Report Number: 1219343-2022-00049
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK060033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 06002-110-EXP-EW
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2016
• 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; Hospitalization
• Patient Sex: Male