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

Model Number 8015

Device Problems Break (1069); Thermal Decomposition of Device (1071); Contamination (1120); Corroded (1131); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/27/2023

Event Type  malfunction  

Event Description

It was reported that the device had burnt iui female.There was no patient involvement.

Manufacturer Narrative

A device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in section h6 of this mdr report.Per 803.52(f)(11)(iii) the information provided was obtained from servicing activities performed on the device.There were no additional details obtainable or provided at the time of service.

Manufacturer Narrative

Correction: describe event or problem.Annex b: b21.Annex c: c21.Annex d: d16.Additional information: device available for eval?, returned to manufacturer on, device return to manuf.?, device eval by manufacturer?, remedial action required, remedial action #, annex a: a1006, a0401, a1801, a27, a040502.Annex b: b01.Annex c: c0601, c07, c11, c02.Annex d: d01, d15, d02.Annex g: g02017, g04037, g04058, g02005, g0405203.

Event Description

It was reported that the device had burnt iui female.There was no patient involvement.

• Brand Name: ALARIS SYSTEM
• 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: 18533287
• MDR Text Key: 333087338
• Report Number: 2016493-2024-10194
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403801549
• UDI-Public: (01)10885403801549
• 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: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8015
• Device Catalogue Number: 8015 ALARIS PCU 1.5 MODULE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-2717-2020
• Patient Sequence Number: 1