MAUDE Adverse Event Report: AVANOS MEDICAL INC. ON-Q EXPANSION KITS WITH SILVERSOAKER ANTIMICROBIAL CATHETER, 7.5 IN (19 CM); CATHETERS

Model Number PM050-A

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

Patient Problems Pulmonary Embolism (1498); Abscess (1690); Bacterial Infection (1735); Cellulitis (1768); Dyspnea (1816); Fever (1858); Pain (1994); Sepsis (2067); Tachycardia (2095); Distress (2329); Fungal Infection (2419); Low Oxygen Saturation (2477); Respiratory Insufficiency (4462); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 04/13/2021

Event Type  Injury  

Manufacturer Narrative

One unopened package code pm050-a from the reported lot was returned.The actual device from the reported incident was not returned.The device history record for the reported lot number, 0008034209, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 13-may-2021 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 avanos medical, inc.Complaint database and identified as complaint (b)(4).Unused device returned.

Event Description

Fill volume: unknown.Flow rate: unknown.Procedure: total laparoscopic hysterectomy (tlh).Cathplace: unknown.It was reported "patient used on-q pump and catheter and developed a pelvic abscess which is growing fungus and bacteroids." the clinical research coordinator detailed the following incident: patient used on-q pump for 72-hours after undergoing minimally invasive hysterectomy procedure.Post-operative course complicated by prolonged fevers and abdominal pain.Patient eventually underwent ct abdomen/pelvis exam, showing an 8 cm mass.Patient admitted to hospital center on (b)(6) 2021.Patient underwent total laparoscopic hysterectomy on (b)(6) 2021 at medical center and received the on-q pump.Patient removed on-q pump on (b)(6) 2021 without any issues but her post-operative course was complicated by fevers and pain at the periumbilical region.She placed several calls to the office regarding post-op pain concerns.She had been taking motrin with some tylenol to reduce fevers, but not taking narcotics as they make her feel weepy.She was passing flatus, having bm [bowel movements], and tolerating po [oral intake].She was diagnosed and treated empirically with a uti [urinary tract infection] and on macrobid, but after her urine sample came back negative, she was switched to keflex 500 mg bid [twice a day] x 7 days for possible cellulitis.On (b)(6) 2021, she was seen in office and reported not to have any evidence of cellulitis, port site hernia, pelvic abscess, or dehiscence.She was afebrile.Patient returned to office (b)(6) 2021 for sustained pain, with significant cramping, and worsening abdominal pain with flatulence and bowel movements so a ct [computed tomography] [of] abdomen/pelvis with iv contrast was ordered.This was performed on (b)(6) 2021 and demonstrated a thick-walled, 8 cm dumbbell-shaped mass and small foci of gas, prompting readmission for the patient for drainage of the pelvic abscess.Patient was admitted to hospital center on (b)(6) 2021 and underwent placement of a drainage catheter by ir [interventional radiology] on (b)(6) 2021.On (b)(6) 2021 she complained of back and abdominal spasms, which she reportedly had been having at home over the last several weeks but worsened after the drain was placed.Patient¿s wbc count increased to 18.9 so id [infectious disease] was consulted, and she was noted to have sepsis, secondary to pelvic abscess with the blood cultures from drainage growing gram positive cocci in clusters.Id added vancomycin.A ct [of the] chest performed (b)(6) 2021 showed small to moderate right and trace left pes [pulmonary embolisms] for which they recommended biopsy.A rapid response was called on (b)(6) 2021 around 3:35 am after the patient experienced a sudden onset of abdominal pain.She was given iv morphine then iv valium to help with pain and muscle spasms.Patient put on [oxygen therapy] 2l nc [nasal canula] and underwent another ct abdomen/pelvis which showed multiple new pelvic collections.She was taken to the or for diagnostic laparoscopy which was converted to ex-lap with washout/enterolysis/evacuation of intraabdominal abscesses/injection of exparel/application of incisional wound vac and removal of drain.By (b)(6) 2021 am, pain well controlled with pca and toradol.[a] ng [nasogastric] tube [was] in place with low volume bilious output.On (b)(6) 2021, patient was febrile and tachycardic to the 120s, reporting subjective chest spasms and sob [shortness of breath]/chest tightness/feverish and patient remained on [oxygen therapy] 2l nc.Cxr chest x-ray], cultures [blood cultures], and repeat labs [laboratory specimens] [were] ordered.Leukocytosis persists but is downtrending.Initial blood cultures demonstrating micrococcus.New aki [acute kidney injury] presents on labs and consult with id recommended addition of antifungal to cover the yeast which grew from the blood culture done on the drainage from (b)(6) 2021, and discontinuation of vancomycin.On (b)(6) 2021, nephrology was consulted due to worsening cr [creatinine] who likely attributed aki to vancomycin and ct iv contrast administration.Underwent thoracentesis by ir (drained 900cc), wound vac changed, nebulizer treatment and picc [peripherally inserted central catheter] placed for tpn [total parenteral nutrition] initiation.On (b)(6) 2021, patient reported some improvement in her sob symptoms, but continues to have increased work of breathing and requiring supplemental o2 and febrile to 38.2.On (b)(6) 2021, patient is still febrile, tmax [the maximum body temperature recorded in a 24-hr period] [was]38.6 [celsius] overnight.Ng tube removed, patient tolerating liquids and had a bm [bowel movement].Cultures from ir drainage (b)(6) 2021 grew c-glabrata and bacteroids caccae.Her blood cultures from (b)(6) 2021 grew micrococcus; (b)(6) 2021 and (b)(6) 2021 blood cultures are negative thus far.Rapid response called at 1400 on (b)(6) 2021.Patient markedly dyspneic/tachypneic with use of accessory muscles.Monitors demonstrated o2 sat in 70-73% on 5l nc, hr [heart rate] 110-120s.Patient placed on nrb [non rebreather] but remained in respiratory distress with significant increased work of breathing.O2 sats remained in low 70s so decision was made to intubate.Anesthesia called to bedside.Patient ambu-bagged and intubated by anesthesia.Note, blood-tinged frothy sputum suctioned.Patient stabilized and transferred to surgical icu [intensive care unit].Patient used on-q pump and catheter and developed a pelvic abscess which is growing fungus and bacteroids.

• Brand Name: ON-Q EXPANSION KITS WITH SILVERSOAKER ANTIMICROBIAL CATHETER, 7.5 IN (19 CM)
• Type of Device: CATHETERS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11828799
• MDR Text Key: 266710840
• Report Number: 2026095-2021-00058
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 00193494135416
• UDI-Public: 00193494135416
• Combination Product (y/n): N
• PMA/PMN Number: K051401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2021
• Device Model Number: PM050-A
• Device Catalogue Number: N/A
• Device Lot Number: 0008034209
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Weight: 75