MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE CB006C HYHSURGPN,400X2-14,CBCMBO,-,OQ,5; ELASTOMERIC - ONDEMAND

Model Number CB006C

Device Problem Activation Problem (4042)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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.Root cause could not be determined.All information reasonably known as of 26-dec-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).(b)(4).The device was not returned.

Event Description

Fill volume: unknown, flow rate: 6ml/hr, procedure: left total knee arthroplasty, cathplace: unknown.An fda user facility report, # (b)(4), was received 02-dec-2019, and the following information was provided: patient with on-q pain ball with bolus button.Bolus button locked in bolus position.Med in use was ropivacaine.Outer bag flat/empty with inner ball still palpable.Med surg nurse called pacu nurse to clarify bolus button and was told to "flip off the blue top lock".Once that came off bolus button rose back to normal position.Patient states that he did not switch dial overnight.Infusing running at 6ml/hr upon assessment.No patient harm.Event date: (b)(6) 2019.

Manufacturer Narrative

Additional information: d1, d4 and g5.All information reasonably known as of 27-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: CB006C HYHSURGPN,400X2-14,CBCMBO,-,OQ,5
• Type of Device: ELASTOMERIC - ONDEMAND
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 9522148
• MDR Text Key: 219778908
• Report Number: 2026095-2019-00205
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• PMA/PMN Number: K181360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CB006C
• Device Catalogue Number: 991046857
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ROPIVACAINE