MAUDE Adverse Event Report: HAEMONETICS PUERTO RICO SQ40¿ MICROAGGREGATE BLOOD TRANSFUSION FILTER; MICROFILTER, BLOOD TRANSFUSION

Model Number	SQ40S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Reaction (2414)
Date of Event	03/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On march 23 2018 haemonetics received notification of an incident in which a hospital patient experienced two reactions following transfusions during a cabg procedure.The hospital reported that the sq40 transfusion filter was not saved following the event, an evaluation of the physical device was not possible.The hospital reported that reactions were considered to be acute, and there was no permanent impact to the patient's health, the patient was able to make a full recovery without further symptoms or interventions.The hospital also reported that the patient received one unit of packed red blood cells and did not experience a reaction to that unit.Based on the available clinical information, it is not possible to identify a causal link between the haemonetics product used and the acute reactions the patient experienced.
Event or Problem Description
On march 23 2018 haemonetics received a report of a patient who experienced two post-transfusion reactions following cpb and protamine administration during a coronary artery bypass grafting (cabg) surgical procedure while using the haemonetics sq40¿ blood transfusion filter which had occurred on (b)(6) 2018.The hospital reported that following each reaction episode the patient received benadryl, solumedrol, epinephrine, levophed and ca++cl-.The patient also received one united of packed red blood cells while on cpb without any complications.The hospital reported "ultimately this was an acute event and no untoward effects following initial treatment.Patient hospital course was uneventful.The patient made a complete recovery without further symptoms or intervention.".

• Brand Name: SQ40¿ MICROAGGREGATE BLOOD TRANSFUSION FILTER
• Common Device Name: MICROFILTER, BLOOD TRANSFUSION
• Manufacturer (Section D): HAEMONETICS PUERTO RICO; carr 194, pall boulevard #98; fajardo 00738
• MDR Report Key: 7443066
• Report Number: 1219343-2018-00007
• Device Sequence Number: 1482482
• Product Code: CAK
• UDI-Device Identifier: 10887691000666
• UDI-Public: (01)10887691000666(17)220731(10)720601
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K960993
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/19/2018

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
• Operator of Device: Physician
• Device Expiration Date: 07/31/2022
• Device Model Number: SQ40S
• Device Lot Number: 720601
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 04/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 69 YR
• Patient Weight: 88