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

Model Number 8100

Device Problems False Alarm (1013); Infusion or Flow Problem (2964)

Patient Problems Therapeutic Response, Increased (2272); Decreased Respiratory Rate (2485)

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: 30873; (2)2426-0500; 8100;8 120; 8015; 60ml bd syringe; 1000ml baxter bag, lot: y318055, exp: mar21, 0.9% sodium chloride injection; 1000ml baxter bag, lot: y316075, exp: feb21, lactated ringer's injection; 1000ml baxter bag, lot: y315341, exp: feb21, lactated ringer's injection; therapy date (b)(6) 2019.The device has been received and an evaluation is pending.A follow up report will be submitted once the evaluation is completed.The customer stated that the patient was an adult patient.

Event Description

It was reported that the patient called the rn into the bathroom because the device was alarming "air in line" on the pump module infusing lactated ringers iv fluids.The patient had a pcu with a pump module infusing lactated ringers 1000ml and a pca pump module infusing dilaudid 25mg/nacl 0.9% 50ml.The rn changed the lactated ringers bag and restarted/reset the device.The device continued to alarm for "air in line." the rn then replaced the lactated ringer iv bag again and the tubing set only to have the device continue to alarm, however, this time the alarm stated a "channel error." a new pump module was added to the pcu and programmed for the lactated ringers iv fluids.The new pump module also alarmed "channel error." at this time the charge rn entered the bathroom to assist.In review, it was decided to change the entire pump set-up, when the lactated ringers tubing set was found to have a balloon in the silicone segment.At 11:30, the pca channel was cleared with demands 1; administered 1; and total drug administered: 2.9.The rn and the charge rn verified the programming to be correct as 1.4mg/12min/8.4mg per hr.The customer later clarified that it is believed that the patient received an additional dilaudid dose which required additional monitoring for respiratory depression, however, there were no medical interventions required to counteract the adverse effects caused to the adult patient from the event.

Manufacturer Narrative

The reported issues of two pump modules alarming for air in line(ail), having a channel error occur, and that a tubing set was found to have ballooned within the silicone segment, were confirmed in the one pump module provided for investigation.Though two pumps (s/n's (b)(6) and (b)(6)) were reported to be involved in the event, only s/n (b)(6) was returned.¿ the investigation of returned pump module s/n (b)(6) found via log analysis that the pump alarmed for air in line, however, the cause was not identified during the investigation.¿ the returned pump had also alarmed with channel error code 240.4150, which is associated with unexpected high pressure detected on the upper (bottle side) pressure sensor; the observed ballooning of the silicone segment was in the vicinity of the upper pressure sensor and is believed to be the cause of the recorded error.¿ testing and inspection of the pump module found no malfunctions and its air in line detection to be within specification ¿ the ballooning of the silicone segment was reproduced in one of the two returned tubing sets.This set was received with a 10ml bd syringe attached at the smartsite valve located on the section of tubing positioned above the pump module.The ballooned tubing was reported under manufacturer report number 916066-2019-03543.The reported issue that it is believed that the patient received an additional dilaudid dose was confirmed to have occurred but is not believed to have been administered in error.This part of the event was reported under manufacturer report number 2016493-2019-01593.¿ all administered pca deliveries recorded were administered after the dose had been requested using the dose request cord.¿ one requested dose was shown to have been recorded simultaneously while the patient history and volume infused data was being cleared; it is believed that this is the dose the customer presumed was an additional dose.¿ inspection and testing of the pca device found no malfunctions and its measuring accuracy to be within specifications.The root cause of ail alarms which would not clear after having hung a new bag was not identified; a device malfunction is not believed to have occurred.The root cause of the channel error is being attributed to the received tubing set which was found to be bulging at the silicone segment in the vicinity of the upper pressure sensor.

Event Description

It was reported that the patient called the rn into the bathroom because the device was alarming "air in line" on the pump module infusing lactated ringers iv fluids.The patient had a pcu with a pump module infusing lactated ringers 1000ml and a pca pump module infusing dilaudid 25mg/nacl 0.9% 50ml.The rn changed the lactated ringers bag and restarted/reset the device.The device continued to alarm for "air in line".The rn then replaced the lactated ringer iv bag again and the tubing set only to have the device continue to alarm, however, this time the alarm stated a "channel error." a new pump module was added to the pcu and programmed for the lactated ringers iv fluids.The new pump module also alarmed "channel error." at this time the charge rn entered the bathroom to assist.In review, it was decided to change the entire pump set-up, when the lactated ringers tubing set was found to have a balloon in the silicone segment.At 11:30, the pca channel was cleared with demands 1; administered 1; and total drug administered: 2.9.The rn and the charge rn verified the programming to be correct as1.4mg/12min/8.4mg per hr.The customer later clarified that it is believed that the patient received an additional dilaudid dose which required additional monitoring for respiratory depression, however, there were no medical interventions required to counteract the adverse effects caused to the adult patient from the event.

• Brand Name: ALARIS® PUMP MODULE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9433918
• MDR Text Key: 173513977
• Report Number: 2016493-2019-01595
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403810015
• UDI-Public: 10885403810015
• Combination Product (y/n): N
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: No
• 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: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H.10