MAUDE Adverse Event Report: HAEMONETICS CORPORATION HAEMONETICS LN8150, DISPOSABLE SET 832F RBC APHERESIS COLLECTION; APPARATUS, AUTOTRANSFUSION

Model Number LN8150

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

Patient Problem Thrombus (2101)

Event Date 04/03/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, during a double rbc collection on haemonetics mc's, a large clot was observed in the plasma bag and small clots were observed in the rbc reservoir bag.Some of the plasma was returned to the donor during this collection.Two add'l incidents also occurred, one on (b)(6) 2019 and the other on (b)(6) 2019.Both of these add'l incidents resulted in the same problem - large clots in the plasma bag and small clots in the rbc reservoir bag.The (b)(6) 2019 incident occurred on sn (b)(4).The (b)(6) 2019 incidents occurred sn (b)(4) which is located at a different collection site than that of the (b)(6) 2019 incident.On (b)(6) 2019, rbc removed all mcs equipment, 15 units, from service and opened a service call with haemonetics.There were two different lots of mcs collection kits involved in these three incidents.Fda safety report id# (b)(4).

• Brand Name: HAEMONETICS LN8150, DISPOSABLE SET 832F RBC APHERESIS COLLECTION
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): HAEMONETICS CORPORATION; braintree MA 02184
• MDR Report Key: 8531406
• MDR Text Key: 142603362
• Report Number: MW5085985
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/16/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2022
• Device Model Number: LN8150
• Device Catalogue Number: 832F
• Device Lot Number: 0119020
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention