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

Model Number 8100

Device Problems Failure to Infuse (2340); Improper Flow or Infusion (2954)

Patient Problems Respiratory Distress (2045); Respiratory Distress (2045); No Consequences Or Impact To Patient (2199)

Event Date 04/30/2020

Event Type  malfunction  

Manufacturer Narrative

Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.

Event Description

It was reported from the 2300 physical rehabilitation that after infusing for an hour, the pump said infusion complete with the medication still full in the bag on the secondary line with 2gram magnesium set to run at 50 ml/hour with a 50 ml volume to be infused and had switched to primary line with ns running at 125ml/hour.Although it was reported that there was a delay in treatment, there was no adverse effects caused to the patient as a result of the event.

Manufacturer Narrative

Correction: d10, h6 patient code, evaluation method, evaluation results & evaluation conclusion codes.Additional information: d11 the reported event that a secondary infusion of 2 grams of magnesium, which was programmed to infuse a volume of 50 ml at the rate of 50 ml/h, completed with the bag of medication still full could not be confirmed or replicated.¿ no conclusion could be drawn through log review regarding the reported experience that the secondary infusion of 2 gram magnesium completed with the 50ml bag still full.O the secondary infusion was programmed to infuse the medication at 10:59:54 am at the rate of 50 ml/h with the volume of 50 ml.The programmed secondary infusion was recorded to have completed at 12:00:50 pm.O the total volume recorded infused during the programmed secondary infusion was 50.011 ml.O the actual bag volume could not be ascertained from the event logs.¿ rate accuracy testing performed found the returned infusion system was infusing within specification.¿ backflow was not observed during check valve failure testing.¿ during internal inspection of administration set, concentricity analysis of the silicone pumping segment found that it was dimensionally within specifications.¿ the inspection process performed on the pump module found no irregularities.The root cause of the reported event could not be identified in this investigation.Device history review: review of the sn (b)(6) service history record showed the device had a manufacture date of 14apr2007.A review of the device service history record was performed beginning from the date of manufacture to the present date 27aug2020 and indicated that this device has been returned for the lvp spring recall on (b)(6) 2008.On (b)(6) 2008, notes indicate the unit was x-ray inspected only; the unit was not serviced.On (b)(6) 2015, this device was returned to "convert to loaner".(b)(6) 2017, this device was converted to recondition.Review of the production failure record was performed beginning from the date of manufacture through present.The failure record showed no production records were opened for the source device.

Event Description

It was reported from the physical rehabilitation unit that after infusing for an hour, the pump said infusion complete with the medication still full in the bag on the secondary line with 2gram magnesium set to run at 50 ml/hour with a 50 ml volume to be infused and had switched to primary line with ns running at 125ml/hour.Although it was reported that there was a delay in treatment, there was no adverse effects caused to the patient as a result of the event.

• Brand Name: ALARIS PUMP MODULE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10084404
• MDR Text Key: 193626742
• Report Number: 2016493-2020-01140
• 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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 05/04/2020

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• 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: 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Treatment: PRI TUBING,8015, THERAPY DATE (B)(6) 2020
• Patient Age: 60 YR
• Patient Weight: 190