MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA EXTERNAL DRAINAGE SET (EDS); EXTERNAL DRAINAGE SYSTEMS

Catalog Number 910110A

Device Problem Leak/Splash (1354)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Type  Injury  

Manufacturer Narrative

The devices were not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A distributor reported on behalf of the customer that the 910110a external drainage set (eds) was attached for cerebrospinal fluid (csf) drainage.It was noted that the csf was leaking out of the burette at the connection where the tubing entered into the "burrette".The external drainage set was changed (2nd unit from the same batch number) and the same issue occurred.Additional information was received on 05dec2018 indicating that the there was a delay in intracranial pressure (icp) monitoring due to the product issue in the intensive care unit (icu) when the external drain was set-up and the problems of csf leaking out of the burette was noted; additional external drainage sets were sourced from the theatre.It was reported that three (3) units of the same lot was used, all with the same problem (the last unit was ¿taped¿ over the burette to stop the leak).A new stock with a different lot number was supplied to the client and the doctor changed the drainage set when stock arrived at the hospital.Currently, the patient is awake and still in the icu with an external ventricular drain with minimal drainage.Additional information received on 12dec2018 indicated that the fault was detected at level 1 ¿ where tubing enters burrette- the fluid was leaking just above number 2 as well- this could have just been excess fluid from the leak at level 1.

Manufacturer Narrative

Two eds units were returned for evaluation.These were visually inspected for defects and a simulation using colored water (to facilitate visibility of water path) was performed.The simulation was performed by placing the eds on an iv pole (vertical position) and water was passed through the line into the burette.Special attention was given to the burette¿s filter cap area which was identified by the customer as the source of the leak.No leaks were observed under normal operating scenario.Dhr review showed that the fg lot complied with all in-process inspections and testing requirements (which include leak testing controls) as specified in the manufacturing shop order and related procedures.No events related to the described condition were reported in the documentation review.The ifu provides certain warning/cautions that must be followed always to ensure proper device performance: do not tip drainage cylinder while inside of cylinder is wet.Do not allow cylinder filter to become wet.Do not overfill the cylinder.Keep the cylinder and check valve upright at all times.Since no leakage was evidenced from a normal operating scenario, other possibilities (against ifu instructions) are: the unit is overflowed.It is used as a container and placed in a non-vertical position.In view of this, the devices were tilted to the side and turned upside-down and water flowed through the filter cap.Nonetheless integrity of filter paper is unknown since the units were submitted to a decontamination process.The burette is made of soft plastic and can be compressed by hand without much effort.If the thin hydrophobic filter paper becomes wet, and then pressurized by deforming/compressing the burette, it will most likely lose integrity/break.The condition could not be confirmed since it could not be reproduced (no leaks observed) under normal operation scenario.No root cause could be determined based on a normal operating scenario.The udi number for catalog 910110a is (b)(4).

Manufacturer Narrative

Additional information was received from the distributor on 31jan2019 : for evd change, the drainage set is attached to the ventricular catheter when the patient is already on the icu bed-which has an iv pole attached to it( bed).So immediately in a vertical position.If it is a tumour case-csf drainage needs to be observed during the case and the drainage set is attached in a vertical position to a mobile iv stand in theatre.This is standard practice for this neurosurgical unit.The leakage was noted when csf reached the burette, so immediately when csf flowed from ventricular catheter to drainage set.The leak occurred on top of the burrette where the inlet is.Two (2) eds units were received in separate bags for evaluation.The lot number could not be confirmed since this product did not have a label on it.The devices were visually inspected and no defect was observed.Since the client had identified the filter cap entrance to the burette as the source of the leak special attention was given to this part.A simulation of normal operating process was performed passing water through the line into the burette.Food coloring was added to the water to facilitate visibility of water path.The eds was placed vertically on a iv pole.The burette was filled all the way to the ¿pressure level¿ line and no leaks were observed from the filter cap on top of the burette.Since no leakage was evidenced from a normal operating scenario, other possibilities (against ifu instructions) are: the unit was overflowed.It was used as a container and placed in a non-vertical position.In view of this, the devices were tilted to the side and turned upside-down and water flowed through the filter cap.Nonetheless integrity of filter paper is unknown since the units were submitted to a decontamination process.The burette is made of soft plastic and can be compressed by hand without much effort.If the thin hydrophobic filter paper becomes wet, and then pressurized by deforming/compressing the burette, most likely will lose integrity/break.Dhr review showed that the fg lot complied with all in-process inspections and testing requirements (which include leak testing controls) as specified in the manufacturing shop order and related procedures.The condition could not be confirmed since it could not be reproduced (no leaks observed) under normal operation scenario.No root cause could be determined based on a normal operating scenario.The udi number for catalog 910110a is (b)(4).

• Brand Name: EXTERNAL DRAINAGE SET (EDS)
• Type of Device: EXTERNAL DRAINAGE SYSTEMS
• Manufacturer (Section D): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• MDR Report Key: 8180989
• MDR Text Key: 130898019
• Report Number: 9612007-2018-00040
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K032817
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 910110A
• Device Lot Number: 1027880749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Date Manufacturer Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR