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HeartMate System Monitor (Thoratec) – Screen Display Problem (2024)

System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in place of values, Unresponsive buttons where the user is unable to initiate a command, which may lead to anxiety /inconvenience, hemodynamic compromise, extended surgical time, and Pump Stop command may be selected

High

FDAMay 8, 2024Nationwide• Thoratec Corp.

BD Multitest 6-Color TBNK (BD) – Immune Assessment Issue (2024)

Multitest with compromised raw material used to assess immune system status may result in flow cytometry plot with unusual staining pattern, nonspecific aggregates, high background, double positive event increase on CD3+CD4+vsCD3+CD8+ and/or CD3-CD16+CD56+vsCD3-CD19+, contaminated antibodies, may lead to erroneous or delayed results, additional patient sample, might impact healthcare decisions

Low

FDA

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HeartMate System Monitor (Thoratec) – Screen Display Problem (2024)

BD Multitest 6-Color TBNK (BD) – Immune Assessment Issue (2024)

VITROS Vitamin B12 Range Verifier (Ortho-Clinical) – Result Verification (2024)

Centrella Smart+ Bed (Baxter) – Mattress Delamination Risk (2024)

Medline ReNewal LigaSure Blunt Tip (Medline) – Packaging Seal Issue (2024)

Medline ReNewal Harmonic ACE+7 Shears (Medline) – Packaging Seal Issue (2024)

CODMAN BACTISEAL EVD Catheter (Integra) – Sterile Packaging Defect (2024)

CODMAN BACTISEAL EVD Catheter (Integra) – Sterile Packaging Defect (2024)

CORI Surgical System (Blue Belt) – Marker Registration Error (2024)

Plum 360 Infusion System Battery (ICU Medical) – Battery Capacity Loss (2024)

CODMAN EVD BACTISEAL Catheter (Integra) – Sterile Packaging Defect (2024)

BD MAX SARS-CoV-2 Reagents (Becton Dickinson) – False Negative Risk (2024)

Plum 360/A+ Spare Batteries (ICU Medical) – Capacity Loss (2024)

Gyn Laparoscopy Kit (American Contract Systems) – Sterilization Issue (2024)

Spine Pack Kit (American Contract Systems) – Sterilization Issue (2024)

Laparoscopy Litho Pack (American Contract Systems) – Sterilization Issue (2024)

Extremity Convenience Kit (American Contract Systems) – Sterilization Issue (2024)

NovaGuide 2 Ultrasound (NovaSignal) – Electrical Shock Risk (2024)

Cataract Pack Kit (American Contract Systems) – Sterilization Issue (2024)

Special Procedure Pack (American Contract Systems) – Sterilization Issue (2024)