MAUDE Adverse Event Report: CAREFUSION SD 8100 ALARIS PUMP MODULE; PUMP, INFUSION

Model Number 8100

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The customer reported problem was confirmed.The device was repaired, retested, and returned to the customer.A review of the device history record in sap for sn (b)(4) was performed from the date of the manufacture to date of the release of product, which confirmed that this device was not involved in a production failure, and product was returned for servicing which correlates to the customer reported issue.A review of the complaint history record in the trackwise was performed for the sn (b)(4) which confirmed no similar complaints with the same or related failure mode.The customer stated that there is no patient involvement.

Event Description

Service: retro: lvp bezel post recall 2017.(b)(4).During the repair process, it was determined that the original problem code should have been broken (broken damaged) for complaint trending purposes file reopened to add track wise pr number to the device data field.This file was initially classified as a level 3 non-complaint for preventative maintenance, upgrade, reconditioning, customer inquiry, or recall which do not require customer advocacy quality review, per (b)(4).This file contained documentation of product deficiency allegations, per (b)(4), and/or repairs (which may or may not have been performed) that are out-of-scope with the initial level 3 non-complaint.Such documentation upgraded the file to a level 2 complaint, per (b)(4), which required a level 2 customer advocacy quality review, also per(b)(4).

• Brand Name: 8100 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: bharatkumar prakash araballi ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 11103517
• MDR Text Key: 224633380
• Report Number: 2016493-2020-87207
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8100
• Device Catalogue Number: 8100
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2012
• 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