MAUDE Adverse Event Report: HALYARD HEALTH ON-Q CATHETER; PUMP, INFUSION

Catalog Number PM050-A

Device Problem Malposition of Device (2616)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cognitive Changes (2551)

Event Date 02/18/2016

Event Type  Injury  

Event Description

On q pain pump catheter was placed by physician.Approximately 10 minutes after placement, patient had a change in cognition and bp dropped to 40 (unreadable) and became unresponsive.First thought related to versed and fentanyl for procedure but pupils were dilated and non reactive.Resuscitation fluid and blood products were administered and patient was eventually intubated.A head ct scan was ordered to rule out stroke.Ct head results showed what appeared to be the on-q pump catheter extending in the interthecal space of the brain."thin catheter-like density noted adjacent to the cervical spinal cord on the left side extending superiorly in to the cerebellopontine angle, suprasellar cistern and into the brain parenchyma in the left frontal lobe.No evidence of intracranial hemorrhage." on q pump was removed by physician and a repeat head ct was done where the catheter was no longer visualized.Upon further review, physician inserted trocar 3 fingerbreadth's from patient's spine, felt no resistance during insertion and no device or placement complications.Physician noted a small amount of clear fluid drained out and that in hind-sight, it was most likely cerebral spinal fluid.Physician noted it should be anatomically impossible to puncture the lumbar and brain but appears may have unintentionally angled the catheter towards the spine as opposed to along the subcutaneous tissue above the ribs.The catheter is about 7.5 cm long and has a 3-10cm skin marks.Patient did not suffer any adverse damages, no bleeding at the site or in the brain and no other interventions were required.

• Brand Name: ON-Q CATHETER
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): HALYARD HEALTH; 43 discovery suite 100; irvine CA 92618
• MDR Report Key: 5494614
• MDR Text Key: 40134704
• Report Number: 5494614
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: PM050-A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/02/2016
• Event Location: Other
• Date Report to Manufacturer: 03/02/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/11/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR