MAUDE Adverse Event Report: HAEMONETICS CORPORATION TOP & TOP RED CELL PROCESSING SET; T&T QUAD RCPL CPD/SAG-M 450ML

Model Number RPT434CCL

Device Problem Partial Blockage (1065)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2020

Event Type  malfunction  

Manufacturer Narrative

A photo was provided which did confirm a kink in the tubing.The tubing sample will not be returned to haemonetics for further evaluation, without physical sample the root cause could not be determined.

Event Description

On (b)(6) 2020 haemonetics was notified of a kink in the needle tubing which occurred during a procedure in saudi arabia, utilizing the top & top red cell processing set - 450ml.There was no reported impact to patients' health.

• Brand Name: TOP & TOP RED CELL PROCESSING SET
• Type of Device: T&T QUAD RCPL CPD/SAG-M 450ML
• 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: 11163190
• MDR Text Key: 227951832
• Report Number: 1219343-2020-00144
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: SA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/17/2020

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
• Device Expiration Date: 01/28/2022
• Device Model Number: RPT434CCL
• Device Lot Number: 2056029
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 01/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2020
• 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