MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR ACCUDRAIN WITHOUT THE ANIT-REFLUX VALVE

Catalog Number INS8400

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Type  malfunction  

Event Description

This is ther first of eight reports (same problem, same product id, same user facility, different incidents).It was initially reported that the external transducer fell off the drain.It had happened to a few units (3).There was no patient injury, no delay, and no revision reported.Additional information was requested and on (b)(6) 2015, the following was received from the customer (charge nurse) regarding the accudrain units: the charge nurse was not present for any of the incidents of transducers falling off but received those reports from the nurses present while she was in charge.The charge nurse reported that there were 4 incidents she was aware of.Date the accudrain was placed or used on the patient = less than three days prior to the incident date originally reported.When was the external transducer connected to the accudrain? = during the external ventricular drainage (evd) insertion procedure, by the neurosurgery resident, the transducer is opened onto the sterile field during preparation and then luer locked by the resident to the evd, with the nurse connecting the pressure cable to the transducer.Date the external transducer fell off the accudrain = unknown.Describe how the transducer was connected to the accudrain (e.G.Was it connected/luer locked in securely (at the red capped port) of the patient stopcock at the zero reference position?) = the transducer was attached at the luer lock stopcock.Describe in more detail how the transducer fell off the drain = in one incident, the transducer fell off while the patient was moved from bed to the ct scanner, while the evd was on the patient's belly.In another, the transducer fell off while the patient was boosted up in the bed, without any undue tugging or pressure placed on the device or cable.I don't know how the last two came off, but i do know that the evd replaced around 1800 of one day had a transducer fall off 24 hours later and had to be replaced again at 1930 the next day, after the patient was boosted and turned in bed without any pressure or tugging on the cable.How long was the transducer connected/being used until it fell off the drain? unknown.How much time elapsed that the transducer was not attached to the accudrain and it was discovered that it had fallen off the accudrain? in the ct incident, it was discovered immediately.In the bed repositioning, it was within five minutes.I don't know the time frame of the first in 24 hours, but the second incident {at 1930 with the boost/turn) what type of transducer was used? brand unknown; it's our standard stocked transducer with cable.What action was taken after the problem occurred? (e.G.Different transducer used, was icp monitoring discontinued, was the accudrain system replaced, etc.) immediately, the stopcock was turned off to patient and a sterile cap was placed over the port where the transducer had been.Accudrain was replaced (the catheter remained in place in the patient, and the drainage burette portion was replaced).Patient age and gender = do not remember which specific patients.Was there any patient harm or injury? if yes, please explain = i don't know that there was any patient harm - we have had some incidence of cns infection on the unit lately, but i have no idea if any of the patients with compromised transducers had infection.Patient outcome- unknown.Additional information was received on (b)(6) 2015 from the integra sr.Clinical educator: integra sr.Clinical educator was with the account on (b)(4) 2015 and had the following observations: the residents usually put/luer lock the external transducer (customer uses icu medical transducer) on tight to the zero reference position port of the accudrain.The accudrain system is placed on an iv pole (skinny ones) and if the accudrain system is just "bumped" a little or if the transducer is just moved up or down very slightly, it disconnects from the accudrain.Sr.Clinical educator tried an edwards lifescience transducer with the accudrain and it yielded the same result.Sr.Clinical educator was told by the account that there were a total of 8 incidents that occurred with the accudrain and in some cases where there were cerebrospinal fluid (csf) leakage.It was unknown at the time of the report which patient/incident had csf leakage.Additional information has been requested.

Manufacturer Narrative

The device involved in the reported incident is not expected to be received for evaluation.An investigation has been initiated based upon the reported information.

• Brand Name: ACCUDRAIN WITHOUT THE ANIT-REFLUX VALVE
• Type of Device: NA
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; anasco PR 00610
• Manufacturer Contact: rowena bunuan ; 315 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4425967
• MDR Text Key: 15109750
• Report Number: 2648988-2015-00002
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: INS8400
• Device Lot Number: 1143938, 1143942, 1142203
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ICU MEDICAL TRANSDUCER (NON-INTEGRA PRODUCT)