MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NEPTUNE 2 ROVER ULTRA (120V); APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Catalog Number 0702001000

Device Problem Off-Label Use (1494)

Patient Problem Death (1802)

Event Date 11/20/2018

Event Type  Death  

Manufacturer Narrative

No alleged device malfunction.

Event Description

It was reported by the customer that during an open abdomen procedure, a patient experienced cardiopulmonary arrest.Per the customer, at the time, the neptune was used as a "wound vac" (vacuum assisted closure) in the procedure, the patient no longer showed vital signs.The customer further reported that a customer employee attempted to use the neptune device to create a "wound vac" to the area where bleeding was profuse.The patient was reported to have died during the procedure.Per the original reporter from the customer, the neptune in no way caused or contributed to the demise of the patient.While it was reported that the neptune did not cause or contribute to the patient¿s condition per the original reporter, using the neptune in conjunction with closed wound drains is a contraindication or usage and could result in a serious injury.

• Brand Name: NEPTUNE 2 ROVER ULTRA (120V)
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: zach baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 8185131
• MDR Text Key: 131031676
• Report Number: 0001811755-2018-02860
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 07613154522309
• UDI-Public: 07613154522309
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132671
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0702001000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death