MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q PUMP 400ML, 5ML/HR; ELASTOMERIC PUMP

Model Number CB001

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

Patient Problem Respiratory Distress (2045)

Event Date 05/17/2015

Event Type  Injury  

Event Description

Fill volume: 400ml.Flow rate: 5ml/hr.Procedure: left ulnar surgery with continuous nerve block.Cathplace: neck.It was reported that a patient experienced shortness of breath while using a pump.The patient had surgery on (b)(6) 2015 and infusion was started.The infusion was given in the patient's home.The symptoms began 48 hours after the start of the infusion.The patient awoke short of breath on (b)(6) evening on (b)(6) 2015.The patient contacted 911 and went to the er.The patient reported that the pump was "just about empty," so eventually the catheter was removed and the patient was discharged.The shortness of breath symptoms resolved after removing the pump.The patient had the on-q patient guidelines.The patient's current condition is reported as "ok".Additional information was received on 05/22/2015.The patient reported that when she first awoke from surgery, the patient was also a little short of breath.At that time, the nurse instructed the patient to clamp the line if further issues arose or if the symptoms worsened.The pump is available for return and evaluation.The infusion was expected to end on (b)(6) 2015 and the patient planned to remove the pump in the afternoon; however, she woke up early with shortness of breath.All the reported symptoms resolved on (b)(6) 2015 by 5:00pm.Additional information was received on 05/26/2015.A nurse reported that the infusion was expected to run for approximately 3 days and that the patient's are educated on use of pump and potential side effects.

Manufacturer Narrative

(b)(4).Method: the device was reported to be returning for an evaluation and at this time is pending return.A review of the device history record (dhr) for the reported lot number was conducted.Results: at this time the investigation is still in progress.Once the device is received, testing will be performed and results will be provided once completed.However, the dhr results indicate that the lot met the process specifications, including the quality control acceptance criteria prior to release.Conclusions: once the investigation and device analysis are completed a follow-up report will be submitted.Information from this incident has been included in our product complaint and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.Device return anticipated.

Manufacturer Narrative

Methods: actual device was received for an evaluation and investigation.Along with the previously reported method, a visual inspection, flow rate accuracy test and pressure pot testing were conducted.In addition, a use review was conducted.Results: the pump was returned partially full.Infusion was verified after opening the pinch clamp.The pump was drained and then refilled to the nominal fill volume.Flow accuracy testing was performed.After 60 hours of testing, the pump yielded a flow rate that was 0.37ml/hr below the minimum specification.Pressure pot testing was performed on the flow restrictor (glass orifice) with the tubing and filter detached from the pump.The tubing was connected to a pressure gauge.After 2 hours of testing, the glass orifice yielded a flow rate that was within specifications with a +/-15% tolerance.Conclusions: the sample evaluation identified that the unit was flowing below the specification limits; however, this is unlikely to have resulted in the reported incident.It was not possible to evaluate the reported reaction complaint; however, per the use review the ropivacaine labeling indicates that when the local anesthetic is injected into the head and neck area, respiratory depression may occur.Subsequently, patients receiving this type of nerve block should have their circulation and respiration monitored and be observed constantly.It was reported that the patient was also taking ultram.The patient's use of both drugs may have contributed to the reported incident.However, the root cause cannot be determined.Based on the results of this investigation, the complaint was not confirmed.As previously requested, the lot met the process specifications, including the quality control acceptance criteria prior to release.An historical review indicated that no other complaints were received that were associated with this lot number.Information from this incident has been included in our product complaint and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.

• Brand Name: ON-Q PUMP 400ML, 5ML/HR
• Type of Device: ELASTOMERIC 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.
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4835827
• MDR Text Key: 5911797
• Report Number: 2026095-2015-00169
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/18/2015

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: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: CB001
• Device Catalogue Number: 101346700
• Device Lot Number: 0202033483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/18/2015
• Initial Date FDA Received: 06/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2014
• 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
• Treatment: ROPIVICAINE 0.2%
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 84