PERFUSION REPORTS

REPORT
030
DATE
TITLE
Faulty Connector On ECMO Soft Shell Reservoir Bag
DETAILS OF INCIDENT

The units custom-made ECMO circuit contains a soft shell reservoir bag to assist with priming and de-airing. During the set-up of an ECMO circuit crystalloid fluid was added to the reservoir bag and the centrifugal head, oxygenator and associated tubing circuit primed passively. After correct positioning of the head in the system driver and applying power to the circuit no flow could be produced. The circuit was checked for obstruction and on close inspection it was found that the outlet of the bag was almost completely adhered to the bag structure. Cavitation was observed in the centrifugal head inlet line. The application of negative pressure to the outlet effectively sealed the bag preventing flow. The seal was pulled apart sufficiently enough to allow flow however slight damage to the bag occurred. The bag is always removed from the circuit prior to the initiation of ECMO and after adequate de-airing this was performed in the usual manner. ECMO was then established in the patient uneventfully.

DETAILS OF INJURY TO PATIENT

None

TYPE OF DEVICE/MANUFACTURER

N/A

ACTION TAKEN

The bag was kept and returned to the manufacturer.
 The other members of the department were made aware of the incident so that the appropriate checks could be made to subsequent ECMO circuits when used.


RESPONSE FROM MANUFACTURER

The following response was received:

"This is an isolated incident, unfortunately caused by an operator error during manufacture. The connector was over bonded when inserted into the outlet at the bottom of the reservoir bag where the bonding together occurred. Operatives have been made fully aware of the issue, an extra quality check along with details of this complaint have been added to the relevant stage of manufacture, which should prevent reoccurrence"



ADDTIONAL INFORMATION

N/A

SUPPORTING VISUALS/VIDEO

N/A

SUPPORTING DOCUMENT

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Detached bullet tip of sump-updated response Sep 2022
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