MAUDE Adverse Event Report: HAEMONETICS CORP PCS®2 PLASMA COLLECTION SYSTEM; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC

Model Number 06002-110-EXP-EW

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

Patient Problems Nausea (1970); Seizures (2063); Vomiting (2144); Dizziness (2194); Sweating (2444)

Event Date 11/16/2016

Event Type  Injury  

Manufacturer Narrative

A haemonetics filed service engineer evaluated the device.The device was run through diagnostics and meets all manufacturer specifications.There was no device issue identified.The device was put back into service.

Event Description

Haemonetics received notification from a customer on 11/17/2016 that during a routine plasmapheresis, a donor experience a seizure.The donor began sweating and was feeling warm and dizzy.The donor then began seizing/convulsing with vomiting.The donation was discontinued at that time with 800ml of plasma collected.The donor did not receive the 500ml of saline which normally would have been administered.Ems was called and the donor was transported to a local emergency room.Follow up with the donor determined that iv fluids were given and then the donor was discharged a few hours later from the emergency department.

• Brand Name: PCS®2 PLASMA COLLECTION SYSTEM
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): HAEMONETICS CORP; 400 wood rd; braintree MA 02184
• Manufacturer (Section G): HAEMONETICS CORP; 400 wood rd; braintree MA 02184
• Manufacturer Contact: julie smith, rn ; 400 wood rd; braintree, MA 02184 ; 7819170643
• MDR Report Key: 6173228
• MDR Text Key: 62330167
• Report Number: 1219343-2016-00088
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Phlebotomist
• Device Model Number: 06002-110-EXP-EW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2016
• Initial Date FDA Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2016
• 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
• Patient Age: 28 YR
• Patient Weight: 96