MAUDE Adverse Event Report: CAREFUSION 2200, INC. V. MUELLER OCHSNER ARTERY FORCEPS; FORCEPS, GENERAL & PLASTIC SURGERY

Model Number SU2800

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Respiratory Distress Syndrome of Newborns (2046); Low Oxygen Saturation (2477)

Event Date 07/28/2023

Event Type  Injury  

Event Description

Patient was born via cesarian section (c/s).Upon arrival to the infant warmer, it was noted the kocher clamp had come undone resulting in significant blood loss.Apgar score was 1 at 1 min and 5 at 5 min.Baby was admitted to special care nursery for respiratory distress, status post resuscitation, and blood loss from umbilical cord.1.5 hours later, nursing noted desaturations and low blood pressure (bp) requiring transition back to continuous positive airway pressure (cpap) and a normal saline (ns) bolus.Pediatrician contacted neonatology with a decision to transfer for higher level of care.In the neonatal intensive care unit (nicu) baby received blood products.Unknown at this time if this was failure of the user to properly clamp or if the clamp itself did not function as intended.

• Brand Name: V. MUELLER OCHSNER ARTERY FORCEPS
• Type of Device: FORCEPS, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CAREFUSION 2200, INC.; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 17457766
• MDR Text Key: 320385625
• Report Number: 17457766
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/01/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: SU2800
• Device Catalogue Number: SU2800
• Device Lot Number: D23XMR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/01/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/04/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/04/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Race: Black Or African American