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U.S. Department of Health and Human Services

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

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HAEMONETICS PUERTO RICO RC HIGH EFFICIENCY LEUCOCYTE REMOVAL FILTER; FILTER, INFUSION LINE Back to Search Results
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.
 
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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 Key6951618
MDR Text Key89386601
Report Number1219343-2017-00030
Device Sequence Number1
Product Code FPB
Combination Product (y/n)N
Reporter Country CodeSF
Number of Events Reported1
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 Date08/31/2020
Device Model NumberRC2VAE
Device Lot Number1550493
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 Received10/16/2017
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 Number1
Patient Outcome(s) Life Threatening;
Patient Age74 YR
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