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 Rash (2033); Burning Sensation (2146); Reaction (2414)

Event Date 08/11/2019

Event Type  Injury  

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 29 aug 2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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 halyard health complaint database and identified as complaint (b)(4).

Event Description

Fill volume: 400 ml.Flow rate: unknown.Procedure: bilateral breast implant removal/capsulatectomy.Cathplace: breast, bilateral.Infusion start time: unknown.Infusion stop time: unknown.It was reported on 11-aug-2019 that the patient developed "rash and hives." the patient's surgeon instructed her to stop pump and all medicine due to hives and rash.Patient was on antibiotics and had been taking po [by mouth] pain medication.Rash started in chest area and moved down into groin and thigh.Patient did not have clamp on tubing.Patient stated she would not be removing the bilateral catheters but would go back to md [medical doctor's] office for removal.During phone conversation, patient decided she would visit er [emergency room].Additional information received 11-aug-2019 indicated the patient received decadron in the er and the catheters were capped.Hospital staff was unable to determine if cause of reaction is antibiotic or pump.Additional information received 12-aug-2019 indicated the patient was feeling better and recapped events from prior day.The rash was first noted near insertion site of catheters on both sides, "rash and then hives that did not itch but felt 'burning' spread across chest and into groin area and upper thigh." patient then felt "whole body was 'swelling up' all over." surgeon was not able to confirm if allergic reaction was due to pump or antibiotic.Both catheters were still in place but capped.Patient stated she was taking ceftin but stopped on (b)(6) 2019 after talking to surgeon and last dose of po pain meds (tylenol with codeine) was on (b)(6) 2019.

Manufacturer Narrative

The actual complaint product was not returned 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 halyard health 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 28-oct-2019 stated the, "patient did not save pump as it was removed in the surgeons office and they ended up letting it infuse after the rash had started.".

• 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: 8949314
• MDR Text Key: 160908533
• Report Number: 2026095-2019-00148
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

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 Model Number: CB004
• Device Catalogue Number: 101347203
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/11/2019
• Initial Date FDA Received: 08/30/2019
• Supplement Dates Manufacturer Received: 10/28/2019
• Supplement Dates FDA Received: 11/21/2019
• Patient Sequence Number: 1
• Treatment: CEFTIN; MARCAINE 0.5% 400ML; TYLENOL WITH CODEINE
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 68