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

Device Problem Failure to Calibrate (2440)

Patient Problem No Information (3190)

Event Date 05/07/2020

Event Type  malfunction  

Manufacturer Narrative

No patient information was provided at this time.The haemonetics field service engineer replaced the line sensor and calibrated to specifications.

Event Description

On (b)(6) 2020 haemonetics was notified by a haemonetics field service engineer of a malfunction with the pcs®2 plasma collection system.During a preventative maintenance visit the line sensor of the system would not calibrate.Patient impact is currently unknown.

• Brand Name: PCS®2 PLASMA COLLECTION SYSTEM
• Type of Device: PCS2,LIST NO. 06002-110-NA
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• Manufacturer Contact: janice kiser ; 125 summer street; boston, ma
• MDR Report Key: 10126680
• MDR Text Key: 194296836
• Report Number: 1219343-2020-00045
• Device Sequence Number: 1
• Product Code: GKT
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/07/2020

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/07/2020
• Initial Date FDA Received: 06/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2007
• 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