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

Catalog Number 0702001000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Memory Loss/Impairment (1958); Brain Injury (2219); Blood Loss (2597)

Event Date 10/23/2014

Event Type  Injury  

Event Description

It was reported that after a pedicle screw posterior lumbar fusion of l4-l5, l5-s1, the surgeon placed a 7mm wide jackson-pratt drain in the muscle beds and closed the fascia.The surgeon then connected the drain tube to neptune suction tubing by pushing the two tubes together with the suction level set to maximum (480 mm-hg).The anesthesiologist noticed the digital volume display read 2700ml.It was also noticed that the patient's ekg was decreasing, co2 levels dropping, and blood pressure dropping.The patient began decompensating.The surgeon completed wound closure and the neptune suction was replaced with a jp bulb on the wound drain.Cpr was administered successfully.The procedure was completed.At the end of the procedure, the reported volume display reading was 3700 ml.The serial number of the device is unknown by the account.There were no reported signs of the neptune malfunctioning.The patient is currently in rehabilitation for an anoxic brain injury due to hypovolemia.

Manufacturer Narrative

Additional information will be submitted once the quality investigation is completed.

Event Description

It was reported that after a pedicle screw posterior lumbar fusion of l4-l5, l5-s1, the surgeon placed a 7mm wide jackson-pratt drain in the muscle beds and closed the fascia.The surgeon then connected the drain tube to neptune suction tubing by pushing the two tubes together with the suction level set to maximum (480 mm-hg).The anesthesiologist noticed the digital volume display read 2700ml.It was also noticed that the patient's ekg was decreasing, co2 levels dropping, and blood pressure dropping.The patient began decompensating.The surgeon completed wound closure and the neptune suction was replaced with a jp bulb on the wound drain.Cpr was administered successfully.The procedure was completed.At the end of the procedure, the reported volume display reading was 3700 ml.The serial number of the device is unknown by the account.There were no reported signs of the neptune malfunctioning.The patient is currently in rehabilitation for an anoxic brain injury due to hypovolemia.

Manufacturer Narrative

The device was serviced for preventive maintenance at the user facility and returned to service.

• 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: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 4299861
• MDR Text Key: 5057821
• Report Number: 0001811755-2014-04389
• Device Sequence Number: 1
• Product Code: JCX
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2014
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0702001000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization; Required Intervention