MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR CSF DRAINAGE SYSTEM W/BLUE STRIPE TUBING & 1-WAY; N/A

Catalog Number INS305

Device Problems Microbial Contamination of Device (2303); Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Death (1802); Meningitis (2389)

Event Type  Death  

Event Description

During jan2017 to jun2017, the critical care department in neurosurgery of (b)(6) has seen an increase of meningitis infection which concerned patients with an external ventricular drainage system (evd).The number of patients infected is 5.The only change was the use of the new evd (8600) since jan2017.Most of the infection has bacteria origin but one case was yeast.One of the patients has neurological after-effects.According to the hospital, the infectious risk is linked to the use of the device due to opening of a closed system when changing the drainage bag.No devices have been kept for evaluation purpose.A hygienic investigation is in progress at the hospital.Linked to mfg.Report numbers: 2648988-2017-00038, 2648988-2017-00039, 2648988-2017-00040, 2648988-2017-00041.

Manufacturer Narrative

Additional information received on 10oct2017 and 11oct2017: the (b)(6) year old male patient had "ventriculite".It was reported that the patient had symptoms of fever, impairment of consciousness, meningitis symptoms.Bacterial culture had been done.It was not specified which of the bacterias (" ? c.Parapsilosis, s.Epidermidis, s.Capitis, e.Coli") was found on this patient.The ins8600 device was used on the patient for 19 days.Lot number of the ins8600 reported as 1170473.The patient was treated with an antibiotic in accordance with the bacteria found.It was reported that pressure was measured on the ins8600.The ins8600 was not kept for evaluation.It was reported that the patient died.

Manufacturer Narrative

Additional information received on 30oct2017 from the user facility with the following: ins305 (pole mount cm and mm rail) is used along with the ins8600.The patient died due to cardiopulmonary arrest during hospitalization for hydrocephalus following subarachnoid hemorrhage by aneurysm rupture.There were some complications respiratory distress with pao and infections (ventriculitis , pneumonia and bacteremia).Investigation completed 14nov2017: the device was not returned to the manufacturer for physical evaluation, therefore the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the device history record review confirmed the labeling, material, and process controls were within specification.

• Brand Name: CSF DRAINAGE SYSTEM W/BLUE STRIPE TUBING & 1-WAY
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; road 402 north, km 1.2; anasco PR 00610
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR 00610
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6886308
• MDR Text Key: 87209870
• Report Number: 2648988-2017-00037
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K972994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: INS305
• Device Lot Number: 1170473
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 70 YR