MAUDE Adverse Event Report: CAREFUSION SD ALARIS SYSTEM; PUMP, INFUSION

Model Number 8100

Device Problems Free or Unrestricted Flow (2945); Mechanics Altered (2984)

Patient Problem Fetal Distress (1856)

Event Date 10/11/2021

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted with investigation results should the device be repaired or the device/logs be received for evaluation.Per 803.52(f)(11)(iii) the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.Device was not returned to manufacturing facility.

Event Description

It was reported that the pump was running faster than what it was programmed.Pitocin was infusing on patient at 1ml/hr.(1mu/min).The patient was noted to have tetanic uterine contractions lasting more than 5 minutes with prolonged fetal deceleration in heart rate.The patient's uterus was firm upon palpation.The staff turned the pitocin infusion off.However, it was noted that the pitocin bag was still dripping slowly.Greater volume appeared to be missing from the bag that what should have been administered.The volume infused shown in the pump was 0.07ml; the approximate volume out of bag was 150-200ml.The iv tubing was clamped and disconnected from patient.The patient received iv fluid bolus, had vaginal exam and position changes as additional intervention.It was mentioned that a bag of lactated ringers was infusing using a different pump module attached to the same pcu.Entire infusion device was replaced.The baby was delivered vaginally with 8/9 apgar score.Both mother and baby are healthy.Later on, the original pump module was tested by the clinicians and the medication was programmed at 1ml/hr to infuse into medicine cup (no patient involved) to check the volume.Initially, pitocin appeared to be dripping appropriately.After approximately 5 minutes, pitocin began dripping rapidly into cup and overflowed a 30ml medicine cup and spilled over onto the floor.Pump was programmed correctly and volume infused read "0.07ml".The hospital's clinical engineering reviewed the device and was able to replicate the issue: free flow was noted noted when low volume infusing, but no issues with higher volume infusion.A copy of sus report was received from fda which states, "pump running faster than what's being programmed.Pitocin infusing on patient at 1 ml/hr (1mu/min) pt noted to have tetanic uterine contraction lasting >5min with prolonged fetal deceleration in hr multiple staff to bedside.Pt's uterus firm to palpation pitocin turned off iv pump channel off but pitocin bag noted to still be dripping slowly.Greater volume appeared to be missing from the bag that what should have been administered.Iv tubing clamped and disconnected from patient pt also had lactated ringers infusing on same iv pump on another channel entire iv pump changed.Later original pump checked by writer and patient's nurse.Pitocin programmed at 1 ml/hr to infuse in medicine cup to check volume.Initially pitocin appeared to be dripping appropriately after approx 5 min, pitocin began dripping rapidly into cup and overflowed a 30ml medicine cup and spilled over onto the floor pump was programmed correctly and volume infused on pump read.07ml pump taken out of service and pitocin and tubing left in channel for biomed to check in the morning clinical engineering reviewed pump and was able to replicate the error free flow noted when low volume infusing, no issues noted with higher volume".This report captures the adverse event on the fetus.For the adverse event report on the mother, please refer to (b)(4).

Event Description

It was reported that the pump was running faster than what it was programmed.Pitocin was infusing on patient at 1ml/hr.(1mu/min).The patient was noted to have tetanic uterine contractions lasting more than 5 minutes with prolonged fetal deceleration in heart rate.The patient's uterus was firm upon palpation.The staff turned the pitocin infusion off.However, it was noted that the pitocin bag was still dripping slowly.Greater volume appeared to be missing from the bag that what should have been administered.The volume infused shown in the pump was 0.07ml; the approximate volume out of bag was 150-200ml.The iv tubing was clamped and disconnected from patient.The patient received iv fluid bolus, had vaginal exam and position changes as additional intervention.It was mentioned that a bag of lactated ringers was infusing using a different pump module attached to the same pcu.Entire infusion device was replaced.The baby was delivered vaginally with 8/9 apgar score.Both mother and baby are healthy.Later on, the original pump module was tested by the clinicians and the medication was programmed at 1ml/hr to infuse into medicine cup (no patient involved) to check the volume.Initially, pitocin appeared to be dripping appropriately.After approximately 5 minutes, pitocin began dripping rapidly into cup and overflowed a 30ml medicine cup and spilled over onto the floor.Pump was programmed correctly and volume infused read "0.07ml".The hospital's clinical engineering reviewed the device and was able to replicate the issue: free flow was noted noted when low volume infusing, but no issues with higher volume infusion.A copy of sus report was received from fda which states, "pump running faster than what's being programmed.Pitocin infusing on patient at 1 ml/hr (1mu/min) pt noted to have tetanic uterine contraction lasting >5min with prolonged fetal deceleration in hr multiple staff to bedside.Pt's uterus firm to palpation pitocin turned off iv pump channel off but pitocin bag noted to still be dripping slowly.Greater volume appeared to be missing from the bag that what should have been administered.Iv tubing clamped and disconnected from patient pt also had lactated ringers infusing on same iv pump on another channel entire iv pump changed.Later original pump checked by writer and patient's nurse.Pitocin programmed at 1 ml/hr to infuse in medicine cup to check volume.Initially pitocin appeared to be dripping appropriately after approx 5 min, pitocin began dripping rapidly into cup and overflowed a 30ml medicine cup and spilled over onto the floor pump was programmed correctly and volume infused on pump read.07ml pump taken out of service and pitocin and tubing left in channel for biomed to check in the morning clinical engineering reviewed pump and was able to replicate the error free flow noted when low volume infusing, no issues noted with higher volume".This report captures the adverse event on the fetus.For the adverse event report on the mother, please refer to mfr report # 2016493-2021-69029.

Manufacturer Narrative

A device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in this mdr report.

• Brand Name: ALARIS SYSTEM
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: brett wilko ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 12743714
• MDR Text Key: 279782346
• Report Number: 2016493-2021-68934
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403810015
• UDI-Public: (01)10885403810015
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/17/2021

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: 8100
• Device Catalogue Number: 8100 ALARIS LVP MODULE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2021
• Initial Date FDA Received: 11/03/2021
• Supplement Dates Manufacturer Received: 10/14/2021
• Supplement Dates FDA Received: 12/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2008
• Is the Device Single Use?: No
• 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 Sex: Male
• Patient Weight: 4 KG