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

Model Number 8100

Device Problems Excess Flow or Over-Infusion (1311); Free or Unrestricted Flow (2945)

Patient Problems Bradycardia (1751); Fetal Distress (1856)

Event Date 05/16/2019

Event Type  Injury  

Manufacturer Narrative

This is the fetus file.The mother file is pr: (b)(4).Manufacturer report number: 2016493-2019-00754.The customer complaint of an over infusion of pitocin was not confirmed or replicated during the investigation.During external inspection the platen lower hinge bracket was found to be misassembled which allowed for some movement of the bottom of the platen from its desired fixed position.The returned pump module was tested for asm rate accuracy and was found to be in specification at -2.7917%.Timed rate accuracy testing was performed at a rate of 10ml/hr measuring 9.55ml/hr (-4.49% error).During testing there were no periods of unregulated flow observed even though the returned pump module passed rate accuracy testing previous investigations have shown that devices with broken platen components can cause over or under infusion conditions to occur, however this depends on how the platen is seated against the pumping segment while infusing.Review of the pcu event logs confirmed three pitocin (oxytocin) infusions were programmed on the day of the reported event.The infusions were programmed at the rate and vtbi reported by the user with no obvious programming errors that would account for the reported an over infusion.No secondary infusions were found to be programmed for the pitocin infusions as reported by the customer.The customer did not return the administration sets in use at the time of the event, therefore no testing could be performed.The root cause of the customer report of an over infusion of pitocin was not definitively determined.

Event Description

It was reported that an 500ml secondary infusion of pitocin which was programmed to infuse at 1 ml/hr however it was noted to be free-flowing into the tubing drip chamber while inducing a female patient in labor and delivery.The primary infusion was 1000ml of an unspecified solution.The rn paused the infusion and clamped the tubing.As a result, the patient had a very painful contraction at 1040 with a 3 minute deceleration down to the 90s.The patient was placed on o2 and was given an iv bolus of terbutaline 0.25 at 10:44 am.The devices were removed from the patient's room and replaced with new devices.The rn could not replicate the free-flow however they were sent to the facility's biomed department.Although requested, there were no further details or information provided and no report of lasting harm.The file for the mother is pr: (b)(4).Received a copy of the customer's medsun report from fda which states, ¿oxytocin was started on pt for labor induction at 1037 all steps for labor oxytocin induction were performed including labor guardrails witnessed by 2 rns when start button was pressed iv was caught free flowing for 1-2 seconds iv was clamped and disconnected from patient immediately".

• Brand Name: ALARIS PUMP MODULE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): 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: 11874412
• MDR Text Key: 252325168
• Report Number: 2016493-2021-506220
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403810015
• UDI-Public: 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2014
• 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
• Treatment: 8015; PRI TUBING; SEC TUBING
• Patient Outcome(s): Life Threatening