MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE UNKNOWN ELASTOMERIC PUMP

Model Number UNKNOWN

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/03/2019

Event Type  malfunction  

Manufacturer Narrative

The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 05-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.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: unknown, flow rate: unknown, procedure: unknown, cathplace: unknown.It was reported there was an issue with the ondemand device.Additional information received 29-jan-2019 stated the red tab was removed prior to use.The bolus button got stuck and would no pop back up within 30 minutes.The patient stated that the bolus button did not pop back up after she pressed the button after an hour, she checked again and it would still not pop back up.The indicator mark was in bottom position.The device was not used with a onq soaker or silversoaker catheter.No additional information was provided.

Manufacturer Narrative

The product involved in the report has been returned and is being processed for evaluation.A lot number was provided.A review of the device history record is in-progress.Upon completion of the sample evaluation and investigation; a follow-up report will be filed.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 device history record for the reported lot number, 0203021721, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.One device was returned for evaluation, the device was evaluated.The investigation summary concluded that the patient care anesthesia (pca) button was not functioning due to drug crystallization in the internal tubing of the pca.The root cause was not identified.All information reasonably known as of 29-apr-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.

• Brand Name: UNKNOWN ELASTOMERIC PUMP
• Type of Device: UNKNOWN ELASTOMERIC PUMP
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 8312232
• MDR Text Key: 136889143
• Report Number: 2026095-2019-00025
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2020
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 0203021721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/29/2019
• Initial Date FDA Received: 02/06/2019
• Supplement Dates Manufacturer Received: 03/14/2019; 04/09/2019
• Supplement Dates FDA Received: 04/02/2019; 04/30/2019
• Patient Sequence Number: 1