MAUDE Adverse Event Report: HAEMONETICS PUERTO RICO RC HIGH EFFICIENCY LEUCOCYTE REMOVAL FILTER; FILTER, INFUSION LINE

Model Number RC2VAE

Device Problem Filtration Problem (2941)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 08/31/2017

Event Type  Injury  

Manufacturer Narrative

Based on the limited information available, haemonetics has determined that the acute, severe hypotensive episodes in close proximity to transfusion would suggest the possibility of leukoreduction filter-triggered events.These episodes are unusually severe for this type of reaction.Hypotensive reactions associated leukoreduction have been linked to beside (not pre-storage) leukoreduction.It is possible that the patient has some type of predisposition that presents for this type of reaction.The history in question raises the possibility for the filters contributing to the hypotension but it does not prove causality.References: heme et al.Transfusion 1996; 36: 904-9; abe et al.Transfusion 1998; 38: 411-412.

Event Description

On (b)(4) 2017 haemonetics was made aware of the following information related to multiple transfusion reactions: on (b)(6) 2017 a (b)(6) male with septicaemia was given a transfusion of ffp through a lps2e leukocyte filter.Within minutes the patient's blood pressure dropped from 149/86 to 40/20.The plasma was stopped and adrenaline given.The patient's blood pressure returned to normal.The patient was also given solu-cortef.Later that evening the patient was given fdp with no problem.On (b)(6) 2017 at 12:50pm the patient was given red cell concentrate through a rc leukocyte filter.Within minutes the patient's blood pressure again dropped to 40/20.The blood transfusion was stopped.Adrenaline was given.The patient's blood pressure returned to normal.On (b)(6) 2017 during the afternoon, the patient was given platelets through a pl3vae leukocyte filter.Within minutes the patient's blood pressure dropped to 40/20.The platelets were stopped.Solu-cortef was given.Blood pressure returned to normal.At 22:30 the patient was given a transfusion of 2 units red cell concentrate using a sq40 microaggregate filter with no adverse effect.

• Brand Name: RC HIGH EFFICIENCY LEUCOCYTE REMOVAL FILTER
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): HAEMONETICS PUERTO RICO; carr 194, pall boulevard #98; fajardo 00738
• Manufacturer (Section G): HAEMONETICS CORP; 400 wood rd; braintree MA 02184
• Manufacturer Contact: david ramsay ; 400 wood rd; braintree, MA 02184 ; 7813487327
• MDR Report Key: 6951618
• MDR Text Key: 89386601
• Report Number: 1219343-2017-00030
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/16/2017

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: Nurse
• Device Expiration Date: 08/31/2020
• Device Model Number: RC2VAE
• Device Lot Number: 1550493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/02/2017
• Initial Date FDA Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 74 YR