MAUDE Adverse Event Report: HAEMONETICS CORPORATION CELL SAVER ELITE+, IE, CS ELITE PROCESSING KIT, 125ML

Model Number CSE-EW-IE

Device Problem Infusion or Flow Problem (2964)

Patient Problem Hypovolemia (2243)

Event Type  malfunction  

Manufacturer Narrative

Disposable lot was manufactured according to approved procedures and met all specifications for release, with no noted manufacturing deviations, nonconformances or capas that would have contributed to the reported incident.As per customer shared photos it was confirmed that the machines return 940ml of certain amount of washed cells however in this case it cannot be confirmed that the issue was caused due to a manufacturing failure of the apheresis harness set.There are no adverse trends or recalls related to this disposable lot involved in this event.There was no report of harm to the patient.

Event Description

On (b)(6) 2022, haemonetics was notified of "underfilling of reinfusion bag.The patient was an acutely unwell cardiac patient who presented after cath lab, for emergency cabg's and who had been systemically anticoagulated pre op as well as intraop and on bypass.Pt was coagulopathic and required multiple clotting components, hrbcs and salvaged blood from me.From 9 cycles i returned 940 mls of arbcs instead of the 1125mls that should have been returned from 9 cycles.This deficit of almost 200 mls meant that the anaesthetist then had to give another unit of hrbcs to this patient.Most of his fluid replacement is based upon aematology and also a volume basis, as is often the case with cardiac patients.There was blood present in the base of the bowl, however not enough to be the deficit of 185mls." there was no report of harm to the patient.The decision to report is based on potential procedure delay in this case.

• Brand Name: CELL SAVER ELITE+, IE, CS ELITE PROCESSING KIT, 125ML
• Type of Device: CELL SAVER ELITE+, IE, CS ELITE PROCESSING KIT, 125ML
• Manufacturer (Section D): HAEMONETICS CORPORATION; 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: 15519297
• MDR Text Key: 306325963
• Report Number: 1219343-2022-00043
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K162423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/02/2022

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 Model Number: CSE-EW-IE
• Device Lot Number: 0122013
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/02/2022
• Initial Date FDA Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization