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

Model Number 8110

Device Problems Break (1069); Thermal Decomposition of Device (1071); Contamination (1120); Corroded (1131); Failure to Calibrate (2440); No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191); Component Misassembled (4004); Physical Resistance/Sticking (4012)

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

Event Date 11/09/2023

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted once the failure investigation has been completed.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.H3 other text : see manufacturer narrative.

Event Description

It was reported that a failure was observed during a planned preventive maintenance or recall remediation service event.There was no reported patient involvement.Bd has learned additional information.It was reported that the syringe module was given to bd associate who was onsite to do a planned preventive maintenance or recall remediation service.When the device was opened, it was found that it had a "small charring and a burning smell coming from the iui board".There was no patient involvement.

Manufacturer Narrative

Correction: 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, a020601, a0509, a0401, a0801, a040502, a1801,a27.Annex g: g02005, g0301204, g04037, g04061, g0201204, g02017, g0204002, g04091.Annex b: b01, b14.Annex c: c06, c07, c1302, c16, c0601, c1601.Annex d: d01, d03 , d15, d0301.

Event Description

It was reported that a failure was observed during a planned preventive maintenance or recall remediation service event.There was no reported patient involvement.Bd has learned additional information.It was reported that the syringe module was given to bd associate who was onsite to do a planned preventive maintenance or recall remediation service.When the device was opened, it was found that it had a "small charring and a burning smell coming from the iui board".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: 18264866
• MDR Text Key: 329679197
• Report Number: 2016493-2023-248413
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403811043
• UDI-Public: (01)10885403811043
• 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: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8110
• Device Catalogue Number: 8110 ALARIS SYRINGE MODULE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2013
• 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-2719-2020
• Patient Sequence Number: 1