MAUDE Adverse Event Report: HALYARD - IRVINE HOMEPUMP C-SERIES 125ML 5ML/HR; ELASTOMERIC LFR

Model Number C125050

Device Problem Infusion or Flow Problem (2964)

Patient Problems Low Blood Pressure/ Hypotension (1914); Nausea (1970); Tachycardia (2095); Dizziness (2194); Decreased Sensitivity (2683)

Event Date 01/29/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products and therapy dates: 300pu infusion of ropivacaine + 200 mcg of fentanyl.The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is in-progress.All information reasonably known as of 27-sep-2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.Avanos medical, inc.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 avanos medical, inc.Complaint database and identified as complaint (b)(4).

Event Description

Fill volume: 125 ml.Flow rate: 5 ml/hr.Procedure: unknown.Cathplace: unknown.Day / time filled pump: (b)(6) 2019.Day / time start infusion: (b)(6) 2019.Day / time end infusion: (b)(6) 2019.Medication: 300pu infusion of ropivacaine and 200 mcg of fentanyl/ diluted in 80 ml of physiological solution, normal saline.It was reported after the surgery, the postoperative analgesia pump infused continuously.The device infused in 6-hours instead of 24-hours.The patient experienced dizziness, nausea, hypotension with a blood pressure 80/50 mmhg, tachycardia, sensory and motor block on legs.Medical intervention involved removing the equipment and administering 1000cc load of hartman solution plus 10 mg of ephedrine intravenous (iv).The pump was above the pump.The patient was eventually discharged.

Manufacturer Narrative

The product involved in the report has been returned and is being processed for evaluation.The device history record for the reported lot number, 0202861596, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of (b)(6) 2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.Avanos medical, inc.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 avanos medical, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.

Manufacturer Narrative

The sample device was evaluated.Flow rate testing was performed and the device met specifications.A root cause was not identified.All information reasonably known as of 26-feb-2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.Avanos medical, inc.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 avanos medical, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.

• Brand Name: HOMEPUMP C-SERIES 125ML 5ML/HR
• Type of Device: ELASTOMERIC LFR
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 9132164
• MDR Text Key: 160907895
• Report Number: 2026095-2019-00157
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 10680651135633
• UDI-Public: 10680651135633
• Combination Product (y/n): N
• PMA/PMN Number: 1
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2020

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: Health Professional
• Device Expiration Date: 05/15/2020
• Device Model Number: C125050
• Device Catalogue Number: 101356302
• Device Lot Number: 0202861596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/06/2019
• Initial Date FDA Received: 09/27/2019
• Supplement Dates Manufacturer Received: 12/10/2019; 02/03/2020
• Supplement Dates FDA Received: 12/17/2019; 02/27/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 71