MAUDE Adverse Event Report: HAEMONETICS CORPORATION LEUKOTRAP® WB SYSTEM; LEUKOTRAP® WB SYSTEM, CP2D/AS3, 500ML, DOUBLE BLOOD BAG WITH SAMPLE POUCH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Alteration in Body Temperature (4568); Insufficient Information (4580)

Event Date 10/08/2022

Event Type  Injury  

Manufacturer Narrative

126-62, lot #: 2256134.Batch production record was reviewed and was found to have been manufactured according to approved procedures and met all specifications for release, with no noted manufacturing deviations, nonconformances or corrective actions that would have contributed to the reported incident.Retains from the lot were visually inspected and no integrity issues identified.Sterilizations records were reviewed and there were no anomalies during any cycles with all parameters within scope.Final test results (including sterility) for 126-62 lot 2256134 were reviewed and no concerns identified.A five-year lookback was performed for the manufacturing site bacteria logged for staphylococcus epidermidis and this is not a known bacterium for the site.The sterilization cycle has been validated to kill these bacteria if it is present.Finished goods testing for this lot shows no colony forming units (cfu's).Haemonetics has received no similar complaints against this product lot.Staphylococcus epidermidis could be introduced to a patient during venipuncture.The bacteria can grow on the skin and enter the blood stream if the venipuncture site is not fully cleaned.It is possible this is what happened in this case.No further information is expected from the reporter.There is no evidence to suggest that the patient reaction or a positive culture result was related to the product used during the procedure.

Event Description

On october 21, 2022, haemonetics was notified of a patient with a febrile transfusion reaction during a transfusion from red blood cells collected using a haemonetics leukotrap® wb system.The customer alleges the blood unit and corresponding segment from the same unit tested positive for staphylococcus epidermidis.Patient's blood cultures tested negative (although some antibiotics had been given prior to collection of patient's blood cultures).There were no specific patient symptoms reported in this event.The hospital has been contacted multiple times for additional information regarding this event with no response.

• Brand Name: LEUKOTRAP® WB SYSTEM
• Type of Device: LEUKOTRAP® WB SYSTEM, CP2D/AS3, 500ML, DOUBLE BLOOD BAG WITH SAMPLE POUCH
• 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: 15828691
• MDR Text Key: 303957675
• Report Number: 1219343-2022-00051
• Device Sequence Number: 1
• Product Code: CAK
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/21/2022

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2022
• Initial Date FDA Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 87 YR
• Patient Sex: Female