MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) C-SERIES HOMEPUMP; PUMP, INFUSION, ELASTOMERIC

Model Number C270050

Patient Problem Chemical Exposure (2570)

Event Type  malfunction  

Event Description

On 9/5 patient initiated on 5-fu infusion with c-series pump model c270050 - 270 ml, 5 ml/hr, lot # 30234039.Infusion centered contacted in the evening of that day by patient's family member with concern for pump leaking.Patient returned to infusion center on 9/6.Patient reports that she noticed fluid accumulating under the clear dressing that holds the sensor.Pump was clamped at the direction of the fellow.Patient with the help of her daughter washed skin with soap and water.Skin clean and dry with no signs of redness or irritation.Pharmacist called to chairside to evaluate pump with registered nurse.Green drape was placed between pump and patient.Pump was unclamped and within a 10 seconds, fluid was noted to leak at the sensor.Pump was clamped and disconnected and returned to pharmacy.Reviewed with physician assistant-certified, received orders for a 24 hour pump at half the dose.Patient continued treatment and returned to center on 9/7, infusion completed and c-series pump disconnected.C-series homepump, c270050 - found to be leaking from the tubing attached to the rate controller.Unable to determine what caused the leak.None was observed prior to pump connection.

• Brand Name: C-SERIES HOMEPUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 17745348
• MDR Text Key: 323554350
• Report Number: MW5145615
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 09/08/2023

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 Model Number: C270050
• Device Lot Number: 30234039
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/13/2023
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Ethnicity: Hispanic
• Patient Race: White