MAUDE Adverse Event Report: HAEMONETICS CORPORATION CELL SAVER ELITE AUTOTRANSFUSION SYSTEM; CELL SAVER ELITE, CM

Model Number CSE-E-CM

Device Problem Obstruction of Flow (2423)

Patient Problem Local Reaction (2035)

Event Date 01/05/2021

Event Type  Injury  

Manufacturer Narrative

Haemonetics sent a field service engineer to evaluate the cell saver elite.Haemonetics field service engineer encountered a pinched valve.The field service replaced valve components and device met manufacturers specifications.The sample was not returned to haemonetics for evaluation; root cause cannot be determined,.

Event Description

On january 6, 2021 haemonetics was notified of an error code 236, 3 to 1 manifold tubing not being installed which was observed during an urgent gynecological procedure, utilizing the cell saver(r) elite system cell saver(r) elite set - 125ml in (b)(6).Blood waste volume was around 1800ml (combination of blood and ac solution).It was then necessary to transfuse allogeneic blood to the patient, patient had a reaction to the transfusion.Following the incident, patient was monitored in icu.Follow up indicated that patients condition stabilized and patient was moved out from icu.

• Brand Name: CELL SAVER ELITE AUTOTRANSFUSION SYSTEM
• Type of Device: CELL SAVER ELITE, CM
• 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: 11257536
• MDR Text Key: 229579403
• Report Number: 1219343-2021-00001
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 308127470166
• UDI-Public: (01)308127470166(22)20D048SPG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K120586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/06/2021

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: Health Professional
• Device Model Number: CSE-E-CM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2021
• Initial Date FDA Received: 02/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2020
• 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
• Patient Outcome(s): Hospitalization; Life Threatening