11

Medical device to avoid Medical device to avoid human error in blood human error in blood

transfusion at patient’s transfusion at patient’s bedside bedside

Medical DeviceClass 1

Council Directive 93/42 EEC

33

Set

Set with BagBlock applied to blood bag door

44

Blood Bank

Put the niche of BagBlock on the bag door. Loop toward the bag

Loop

Put the niche of BagBlock on the bag door. Loop toward the bag

55

Blood Bank

Apply BagBlock device to blood bag door

66

Blood Bank

BagBlock applied to blood bag door

Loop

77

Blood Bank

Insert the loop of BagBlock in a hole of blood bag

88

Blood Bank

BagBlock applied to blood bag door

99

Blood Bank

BagBlock applied to blood bag door (bottom view)

1010

During blood drawing

Department

Identification of the patient

1111

During blood drawing

Department

Identification data of the patient on wristband

1212

Department

Send request of identification of the group, with wristband, to the Blood Bank

During blood drawing

1313

AB

Negativo

Blood Bank

Determination of receiver’s ABO group and Rh factor and selection of WatchControl identical with group and Rh factor of the receiver

1414

Blood Bank

Insert WatchControl into wristband and fix with permanent block

1515

AB

Negativo

Blood Bank

Send documentation and WatchControl to the Department

1616

Department

The patient is identified with his own group by WatchControl

1717WatchControl identifies the patient’s group

Department

1818

3

AB Negativo

Department – Operating Theatre

Form for blood bags requested by Department/Operating Theatre

1919

Blood Bank

Selected n° bags to instill, compatible, requested

3

AB Negativo

2020

Blood Bank

Preparation for crossmatch

2121

3

AB Negativo

Blood Bank

Crossmatch to verify ABO compatibility between receiver and donor unit

2222

3

AB Negativo

Blood Bank

From the form you know the group of the receiver

2323

3

AB Negativo

Blood Bank

Select n° KeyBlood identical to the group of the receiver

2424

Blood Bank

Insert KeyBlood into CapKey

2525

Blood BankBlood Bank

Inserted KeyBlood into CapKey

2626

3

Blood Bank

Selected KeyBlood to insert at BagBlock

2727

Blood Bank

Inserire CapKey in un foro del BagBlock

Blood Bank

Insertion of CapKey to BagBlock

2828

3

Blood Bank

Send the requested bags to Department/Operating Theatre

2929

Reparto/S.O.At patient’s bedside

Department – Operating Theatre

Remove, by torsion, CapKey from BagBlock applied to the bag

3030

Department – Operating Theatre

At patient’s bedside

Open the WatchControl

3131

Reparto/S.O.Department – Operating Theatre

At patient’s bedside

Insert the CapKey into the WatchControl

3232CapKey into WatchControl

Department – Operating Theatre

At patient’s bedside

Stud

3333

Reparto/S.O.Department – Operating Theatre

At patient’s bedside

By pressure on the cap of WatchControl, the stud releases the KeyBlood if….

3434

Department – Operating Theatre

At patient’s bedside

If there is identity of group you can relaese the KeyBlood from CapKey

3535

Reparto/S.O.Department – Operating Theatre

At patient’s bedside

Draw KeyBlood from WatchControl at the wrist of the patient

3636Put KeyBlood into BagBlock with writing upwards

Department – Operating Theatre

At patient’s bedside

3737

Department – Operating Theatre

At patient’s bedside

The KeyBlood is ready to be inserted into BagBlock

3838

Reparto/S.O.Department – Operating Theatre

At patient’s bedside

Put KeyBlood into BagBlock with writing upwards

3939

Reparto/S.O.

Push the button to open BagBlock

Department – Operating Theatre

At patient’s bedside

4040

Reparto/S.O.

Push the button to open BagBlock (bottom view)

Department – Operating Theatre

At patient’s bedside

4141

Reparto/S.O.Department – Operating Theatre

At patient’s bedside

By pressure, release the blood bag from BagBlock

4242

At patient’s bedside

Proceed to the transfusion through the released door

Department – Operating Theatre

4343

I want Blood Safety

4444

Department – Operating Theatre

At patient’s bedside

BagBlock device remains hanging from the bag by the loop

4545

Reparto/S.O. Department – Operating Theatre

At patient’s bedside

KeyBlood device remains blocked into BagBlock device of each bag

4646

Reparto/S.O.

Draw and throw the CapKey

Department – Operating Theatre

At patient’s bedside

4747Close again the WatchControl

Department – Operating Theatre

At patient’s bedside

4848

Department – Operating Theatre

At patient’s bedside

The patient has at his wrist the WatchControl for other transfusions

4949

5050

Diploma Prize of the Delegation of the People's Republic of China, Geneva 1998