MAUDE Adverse Event Report: HAEMONETICS CORPORATION CELL SAVER® ELITE® PLUS AUTOTRANSFUSION SYSTEM; UNIT SHIP PACK ASSEMBLY, ELITE

Model Number CSE-E-XX

Device Problems Incorrect Measurement (1383); Blocked Connection (2888); Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 07/27/2021

Event Type  malfunction  

Manufacturer Narrative

There were no safety issues or adverse events reported for patients treated.Customer discontinued using system.Investigation is pending as system was stated to have been shipped to haemonetics for further investigation.Once system is received by haemonetics, the system will be investigated regarding the defects communicated and to determine potential root cause.

Event Description

On (b)(6) 2021 haemonetics was notified of multiple errors that were observed during a procedure in spain, utilizing the cell saver® elite® autotransfusion system.The first error reported was a line sensor error where the customer stated that the line sensor was blocked and could not detect that the effluent line was mounted.In this case the system was restarted and ran normally but then error would reoccur.The second error reported was the bar code reader not reading.The third error reported, the system would freeze, touch screen not responding, and the system would have to be restarted.The last reported error was the amount of liquid processing not being accounted for by the system.

Manufacturer Narrative

Investigation findings: device data logs were reviewed; seven user errors were found archived in the system.Haemonetics serviced the unit and multiple parts were replaced as part of recommended maintenance.Quality system visual evaluation found no device anomalies from manufacturing that may have contributed to the reported issue.The device history record shows the device met specifications at final manufacturing testing and there were no nonconformance events associated with this complaint.The root cause was found to be related to multiple user errors.Corrective action was taken by haemonetics to perform distributor and customer refresher training on the operation and maintenance of the cell saver elite/+system.

• Brand Name: CELL SAVER® ELITE® PLUS AUTOTRANSFUSION SYSTEM
• Type of Device: UNIT SHIP PACK ASSEMBLY, ELITE
• 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: 12375651
• MDR Text Key: 268470534
• Report Number: 1219343-2021-00120
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K120586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CSE-E-XX
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2012
• 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