MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,7.5",EXP KT,-,OQ,5; INFUSION PUMP

Model Number PM050-A

Device Problem Use of Device Problem (1670)

Patient Problems Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Decreased Respiratory Rate (2485)

Event Date 02/18/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Udi # unknown.Method: the actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Results: as the device was unavailable for analysis, no methods were performed.Therefore, results cannot be obtained.Conclusions: the device was not returned to halyard for evaluation therefore, we are unable to determine the cause for the reported event.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).Device not returned.

Event Description

This is a medwatch from the fda: "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 intrathecal space of the brain.¿thin catheter ¿like density noted adjacent to the cervical spinal cord on the left side extending superiorly in to the cervellopoinine 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 fingerbreadths 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 angle 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 3-10 skin marks.Patient did not suffer any adverse damages, no bleeding at the site or in the brain and no other interventions were required." additional information received on 21-mar-2016 from the physician stated that this incident was indeed a use error.

• Brand Name: SURGPN,7.5",EXP KT,-,OQ,5
• Type of Device: INFUSION PUMP
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana, b.c. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 5576411
• MDR Text Key: 42663225
• Report Number: 2026095-2016-00030
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK051401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/16/2016

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?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: PM050-A
• Device Catalogue Number: 101354100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/16/2016
• Initial Date FDA Received: 04/14/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR