MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 600 ML, 2-14 ML/HR; ELASTOMERIC - SAF

Model Number CB6004

Device Problem Infusion or Flow Problem (2964)

Patient Problems Anxiety (2328); No Code Available (3191)

Event Date 10/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 25-oct-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.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.The device was not returned.

Event Description

Fill volume: 750 ml, flow rate: 8ml/hr, procedure: shoulder, cathplace: unknown, start date and time: (b)(6) 2019 at 1820, end date and time: (b)(6) 2019 at 1400.It was reported a nurse from the pain clinic states she received a picture of the patient's pump and it was empty.The nurse went to meet the patient in the hospital to visualize the pump.The pump was empty, the select-a-flow (saf) was on 8ml/hr, not adjusted and zip tied closed.The patient complained of some shortness of breath and feeling anxious, there were no other reported signs or symptoms.

Manufacturer Narrative

The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 20-nov-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.

Event Description

Additional information areceived 11-nov-2019 stated followed-up information from the customer reports risk management has reported the event to the fda.

Manufacturer Narrative

The device history record for the reported lot number, 0002999004, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.One sample device was returned.The device was evaluated and flow accuracy testing was performed.All tested rates met specification.The failure was not confirmed.A root cause was not identified.All information reasonably known as of 07-feb-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

All information reasonably known as of 13-jan-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.

Event Description

Additional information received 18-dec-2019 to report mw 5091469 report stated: device was ordered and filled to max dose of 750ml at 8cc/hr (93 hour infusion time).It was found to have infused over 2 days instead of intended 4 days.No injury to patient.

• Brand Name: ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 600 ML, 2-14 ML/HR
• Type of Device: ELASTOMERIC - SAF
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 9243132
• MDR Text Key: 177594137
• Report Number: 2026095-2019-00177
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/07/2020

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: 11/19/2021
• Device Model Number: CB6004
• Device Catalogue Number: 101347603
• Device Lot Number: 0002999004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 10/29/2019; 12/18/2019; 01/15/2020
• Supplement Dates FDA Received: 11/21/2019; 01/13/2020; 02/07/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other