MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE ON-Q PUMP WITH SELECT-A-FLOW; ELASTOMERIC - SAF

Model Number CB004

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Fever (1858); Chills (2191); Shaking/Tremors (2515)

Event Date 01/25/2020

Event Type  Injury  

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 17 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.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: 540 ml.Flow rate: 8 ml/hr.Procedure: hysterectomy.Cathplace: superior to pelvic symphysis.Infusion start time: (b)(6) 2020 14:00.Infusion stop time: (b)(6) 2020 22:00.It was reported that the patient came "to the emergency department and was admitted to the hospital.[the patient] complained of abdominal pain and was found to have a fever." the user facility stated that it was believed the patient "may have had a possible pelvic infection related to the pump." additional information received 30-jan-2020 included patient demographics.The treatment/intervention performed was "broad-spectrum antibiotics treatment." patient outcome was listed as "recovered." patient diagnosis was "postoperative fever" with symptoms of generalized abdominal pain, chills, tremors, mild fever.The physician "believes the [device] may possibly be related to the post-operative fever resulting in hospitalization.The patient expressed a decrease in symptoms temporarily upon removal of the catheter.Post-operative infections do not typically occur as early as this patient's incident." "approximately 48 hours after the pump was placed, at around 6pm on (b)(6) 2020 the patient experienced chills and tremors and suspected a fever while at home.She took her temperature at this time and had a minor temperature elevation of 99.4f.She had generalized abdominal pain which was not relieved by oxycodone, ibuprofen or tylenol.She denies redness or localized pain at the catheter site.She decided to remove the pump catheter around 10pm on (b)(6) 2020 and proceeded to the emergency department.[the patient].Expressed a decrease in symptoms upon removal but the symptoms reoccurred.Upon arrival to the ed [emergency department] at 11pm her temperature was 98.8f.She denies symptoms of tachycardia or diaphoresis." pump was filled by outpatient pharmacy and was filled by syringe.Five hours elapsed between filling the pump and starting the infusion.The pump was not refilled.The patient was given instructions on how to maintain the pump and how to remove the catheter when the pump is empty.The last facility in-service was on (b)(6) 2019.The flow rate was not changed during therapy, the flow rate dial key was removed, and a wrap tie was used to secure the device.

Manufacturer Narrative

The device history record for lot 0002976702 was reviewed and the product was produced according to product specifications.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 08 may 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 comp-ghc-20-00306.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: ON-Q PUMP WITH SELECT-A-FLOW
• Type of Device: ELASTOMERIC - SAF
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 9717599
• MDR Text Key: 188345425
• Report Number: 2026095-2020-00025
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 10680651134728
• UDI-Public: 10680651134728
• Combination Product (y/n): N
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/08/2020

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/25/2021
• Device Model Number: CB004
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 0002976702
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/27/2020
• Initial Date FDA Received: 02/17/2020
• Supplement Dates Manufacturer Received: 05/05/2020
• Supplement Dates FDA Received: 05/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IBUPROFEN; NORMAL SALINE; OXYCODONE; ROPIVACAINE; TORADOL; TYLENOL
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 60