MAUDE Adverse Event Report: AVANOS MEDICAL INC. AMBIT CASSETTE - FILTER, SPIKE; ELECTRONIC INFUSION PUMP ACCESSORIES - STERILE

Model Number	220140
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is in-progress.All information reasonably known as of 14 oct 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 complaint database and identified as complaint comp-(b)(4).
Event or Problem Description
It was reported that a pump connected to a patient for chemotherapy purposes flowed too fast.The medication in the pump was trabectedin.Per additional information received 29 sep 2020, there was no injury to the patient after the fast flow incident.The medication should have infused over 16 hours, but instead the bag was empty at around 6 hours.Per additional information received 2 oct 2020, the customer believes it is a faulty cassette, not the pump, which caused the fast flow.The customer switched to a different lot of cassettes and no further incidents have occurred.
Additional Manufacturer Narrative
The device history record for lot e916811 was reviewed and the product was produced according to product specifications.All information reasonably known as of 03 dec 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 complaint database and identified as complaint comp (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: AMBIT CASSETTE - FILTER, SPIKE
• Common Device Name: ELECTRONIC INFUSION PUMP ACCESSORIES - STERILE
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10683309
• Report Number: 1722214-2020-00006
• Device Sequence Number: 11553955
• Product Code: FRN
• UDI-Device Identifier: 00857595005046
• UDI-Public: 00857595005046
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K052221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/17/2022
• Device Model Number: 220140
• Device Catalogue Number: N/A
• Device Lot Number: E916811
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 12/04/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRABECTEDIN.