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

Model Number 8100

Device Problems Corroded (1131); Disconnection (1171); Fracture (1260); Communication or Transmission Problem (2896); Device Contamination with Chemical or Other Material (2944); Premature Separation (4045)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Syringe, therapy date unk.Quality improvement coordinator.Requested patient demographics however not provided.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

The customer reported that during multiple infusions on several modules, the rn reported that the one lvp disconnected and the 2nd lvp attached to the pcu disconnected and fell to the ground, requiring both modules to be reprogramed.It was reported that the other modules attached reported no issues with disconnection.There was no report of patient or user harm.The biomed examined the 2 lvp¿s modules and noted a "cracked case on one of the lvp and large amount of sticky fluid (possibly dried saline) that was imbedded into the sliding portion of the ¿latch¿ (presuming iui connector) and causing it to not to ¿snap¿ into place and secure the module that fell.Biomed stated that ¿once the devices were cleaned it functioned as intended.".

Manufacturer Narrative

The customer provided photo observed dried fluids on the pump module release latch assembly.The dried fluids are embedded into the sliding portion of the release latch assembly.The customer provided photos do confirm the reported issue.However, the customer reported that the devices do not need to be sent in for evaluation and they will perform the necessary repairs/cleaning that is needed.

Event Description

The customer reported that during multiple infusions on several modules, the rn reported that the one lvp disconnected and the 2nd lvp attached to the pcu disconnected and fell to the ground, requiring both modules to be reprogramed.It was reported that the other modules attached reported no issues with disconnection.There was no report of patient or user harm.Although requested, no further details were provided by the customer for this event.The biomed examined the 2 lvp¿s modules and noted a "cracked case on one of the lvp and large amount of sticky fluid (possibly dried saline) that was imbedded into the sliding portion of the ¿latch¿ and causing it to not to ¿snap¿ into place and secure the module that fell.Biomed stated that ¿once the devices were cleaned it functioned as intended." it was later reported that tpn fluid was noted on release latch assembly.

• Brand Name: ALARIS PUMP MODULE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8449741
• MDR Text Key: 139827013
• Report Number: 2016493-2019-00315
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403810015
• UDI-Public: 10885403810015
• Combination Product (y/n): N
• PMA/PMN Number: K950419
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• 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?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015,SYR TUBE,(3)PRI TUBING,(2)8100,8110, TD UNK