MAUDE Adverse Event Report: DMS HOLDINGS, INC. MABIS; CLAMP, UMBILICAL

Model Number 9423

Device Problems Defective Device (2588); Difficult to Open or Close (2921); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Cyanosis (1798); Respiratory Distress Syndrome of Newborns (2046); Muscle Hypotonia (4531)

Event Date 09/18/2021

Event Type  malfunction  

Event Description

Cord clamp failed to clamp/close correctly x3 times, delaying cord clamping and the remainder of resuscitation for newborn.Patient was born via c/s (cesarean section) after a tolac (trial of labor after cesarean) that failed to progress at 7 cm, meconium staining was noted of amniotic fluid, along with maternal chorioamnionitis; baby was delivered floppy, blue, and without spontaneous respirations, and did not respond to w/d/s (warmed/dried/stimulated = process of newborn resuscitation) so delayed cord clamping was called at 15 seconds of life.Immediately, the obgyn mds clamped the cord, but the second clamp would not appropriately close, and they tried 3 separate times while calling out to the scrub tech that it was not working.They got a new cord clamp to replace the defective one, but by that time, we had lost almost 20-30 seconds and were closer to 1 minute of life.Due to defective equipment (cord clamp), resuscitation of this infant was delayed by nearly 30 seconds.The nrp (neonatal resuscitation program) algorithm was paused and remained at w/d/s due to being unable to bring the infant to the warmer.The obgyn doctors, the scrub tech, and myself (the resident) w/d/s-ing the infant were not at fault for an lapse in care.This was due to the equipment malfunctioning.To prevent this in the future, better cord clamps or equipment could be acquired.Scrub techs could test out the clamps prior to giving them to the obgyns.If these clamps are re-used (i'm not sure the process behind sterilizing or throwing these away), they should probably be wasted sooner than later since they appear to have a shelf life of when they stop working as well.There was no detectable harm in this event.This is not a recurring issue.The device has been discarded.

• Brand Name: MABIS
• Type of Device: CLAMP, UMBILICAL
• Manufacturer (Section D): DMS HOLDINGS, INC.; 1931 norman dr; waukegan IL 60085
• MDR Report Key: 12656124
• MDR Text Key: 277162166
• Report Number: 12656124
• Device Sequence Number: 1
• Product Code: HFW
• 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: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9423
• Device Lot Number: 0G06
• 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: 09/28/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1