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

Model Number 8100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Extravasation (1842); Tissue Damage (2104)

Event Date 11/15/2020

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: the customer¿s reported complaint of a pump module involved in an infiltration was not confirmed during the investigation.Based on log analysis results, the last recorded infusion on the date of the reported event was logged between (b)(6) 2020 at 7:00 pm and (b)(6) 2020 at 05:05 am by the source pump module s/n (b)(4).There was no evidence in the logs that would attribute to the reported incident.Test results demonstrated the source pump module passing patient side occlusion testing, indicating it is operating in specification.Device inspection: an external and internal inspection of the customer¿s source.Pump module observed the male and female iui connectors contact pins with corrosion and white dried residue.There were no other obvious issues or anomalies observed during the inspection of the device.The incident administration set was not returned and could not be inspected.Root cause analysis: the root cause of the customer¿s experience of an infusion infiltrating was not identified, however the pump module is neither designed nor intended to detect infiltrations and may not alarm under infiltration conditions.Device history review: review of the pump module s/n (b)(4) service history record showed the device had a manufacture date of 24oct2014.A review of the device service history record was performed beginning from the date of manufacture to the present date 03dec2020 and indicated that this device has not been returned to service.Review of the production failure record was performed beginning from the date of manufacture through present.The failure record showed no production failure records were opened for the source device.

Event Description

It was reported that the large volume pump (lvp) was involved in an infiltration and resulted in surgery and prolonged hospitalization.It was noted that there were 3 lvps that were attached to the pcu and it is unknown which lvp was involved in the event.The event occurred in the intensive care unit (icu).The customer stated no further information is available.

• 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: sean cole ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 11019373
• MDR Text Key: 221766749
• Report Number: 2016493-2020-61229
• 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: company representative,other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• 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: 12/01/2020
• Is the Reporter a Health Professional?: Yes
• 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: (3) PRI TUBING, 8015, (2) 8100, TD (B)(6) 2020
• Patient Outcome(s): Required Intervention