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Table 2 Potential failures of the morphine PFS system and recommendations identified by FMEA

From: Standardised concentrations of morphine infusions for nurse/patient-controlled analgesia use in children

Potential Failure

Causes

Effects

S

P

D

RPN

Recommendations

Staff prepare N/PCA infusion from ampoule using the previous system (based on patient weight)

PFSs stock not updated quickly or prefilled syringe expired.

Possible of delay in patient receiving morphine dose as individualized syringe can’t be administered using the standard syringe programs on the pump, as protocols on the pump are for standard concentrations only.

2

8

1

16

− Nurse review stock levels

− Protocols need to be clear about preparing standard concentrations from ampoules in ward in emergency (pharmacy)

Run out-of-stock quickly at ward level

No enough space to store PFSs and drug room temperature is above recommended temp, > 25 °C.

PFSs not available when required. Delays in patient receiving morphine injection

4

10

1

40

− Additional air conditioning in drug storage area (matrons)

− Use Omnicell (electronic storage cabinets) for storage as temperature controlled (pharmacy)

Run out-of-stock in paediatric pharmacy dispensary area

No enough space in paediatric pharmacy dispensary area to accommodate large number of the three strengths.

Limited number of PFSs stored at wards level.

4

6

1

24

− Increase stock levels at paediatric Pharmacy

− Consider using Omincell for CD storage in paediatric pharmacy dispensary area, wards, and theatres (Pharmacy)

Choosing the wrong strength of the PFS

Picking syringe by label, not by barcode.

Wrong dose given to patient

10

3

2

60

− Separate storage for each strength, with clear labelling, on the wards/theatre (Pharmacy)

− Write weight between brackets in large font on the syringe label

(pharmacy manufacture)

− Introduce the use of barcodes for syringe’s label, prescriptions’ label.

Syringe Drive procedure incompatibility with manually made up solution in Emergency Department

Misinterpretation of fall-back case – Is manually mixing equivalent to PFSs, or follow previous procedure?

Would have to select standard concentrations

5

1

2

10

Protocols and SOPs on how to use standard concentrations should be made clear to all clinical areas, including Emergency Department.

(Pharmacy)

  1. FMEA: Failure Mode and Effects Analysis; N/PCA: Nurse- or/ Patient-Controlled Analgesia; PFS: prefilled syringe; SOPs: standard operating procedures; S=Severity; P=Probability; D = Detectability; RPN: risk priority number calculated as RPN = S x P x D; CD: controlled drug