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

Model Number 06002-110-NA-EW

Device Problems Pumping Problem (3016); Insufficient Information (3190)

Patient Problems Tingling (2171); Chest Tightness/Pressure (2463)

Event Date 08/08/2015

Event Type  Injury  

Manufacturer Narrative

Device evaluation pending.Evaluation in progress.

Event Description

(b)(6) center contacted haemonetics on (b)(6) 2015 to report an adverse event of a donor.The plasmapheresis was started and during the first return cycle, excessive anticoagulant entered the bowl.The donor began to complain about tingling from the mouth to mid-chest area.The donor then informed the medical staff they were experiencing chest pressure and was a "2" on a pain scale of 1-10.The donor also stated feeling pain in the right arm above the venipuncture site.The donor then informed the medical staff that the chest pressure was more like a tightness in the chest.Ems was called and the donor was transported to the local hospital.The center does not have any treatment or donor outcome information.

Manufacturer Narrative

A review of the device history record was performed; no anomalies were found that may have contributed to the reported issue and the device met all specifications upon release.Complaint trend analysis was reviewed for this device and failure mode; no adverse trends were noted.During an on-site evaluation of the reported device, diagnostics and functionality checks were performed in accordance with the manufacturer's specifications.It was found that the durometer of the rollers on the ac rotor were below specification.The pump rotor was replaced and the device was returned to service without any other issues noted.A corrective action (ca(b)(4)) has been opened to investigate durometer changes in rollers on the ac rotor.The investigation is analyzing whether methods and chemicals used by institutions to clean the device may impact the ac rotor.Results of the analysis may be used to provide institutions with additional clarification on device cleaning.Changed to adverse event and product problem.Changed date to reflect the date of evaluation.

Manufacturer Narrative

Recall box checked as haemonetics has filed a medical device safety alert.Haemonetics awaiting fda correction/removal reporting number.

• 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: 5097084
• MDR Text Key: 26546953
• Report Number: 1219343-2015-00010
• 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
• Remedial Action: Recall
• Type of Report: Followup,Followup
• Report Date: 08/25/2015

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?: Yes
• Device Operator: Phlebotomist
• Device Model Number: 06002-110-NA-EW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/11/2015; 12/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 26 YR
• Patient Weight: 62