MAUDE Adverse Event Report: CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET; SET,ADMINISTRATION,INTRAVASCULAR

Model Number 2426-0007

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Pain (1994); Swelling (2091)

Event Date 07/03/2019

Event Type  malfunction  

Manufacturer Narrative

The customer¿s report of an over infusion of vancomycin was not confirmed in the logs; however, during testing of the administration and secondary sets fluid was observed back flow into the primary administration set was observed.There were no obvious programming errors observed in the pcu event log.Timed rate accuracy testing performed on the source pump module found the device operating in specification.During testing of the administration set, back flow was observed.Back flow into the primary iv bag can give the impression that an infusion completed sooner than expected.Concentricity analysis of the silicone pumping segment found the wall maximum is marginally out of specification.It is not believed that this contributed to the customer reported event.Inspection of the pumping mechanism found no irregularities.The root cause of the cause of the customer's report could not definitively be confirmed, however the probable cause of the complaint of an over infusion was believed to the result of a back flow event.

Event Description

It was reported the iv pump was programmed at a rate of 200ml/hr to infuse vancomycin 200ml.The infusion was started on (b)(6) 2019 at 1214 and stopped at 1238 due to patient compliant of arm swelling and pain.The infusion report shows that only a volume of 36.2ml was infused during those 24 minutes, however the iv bag was found to be empty.The event resulted to iv site infiltration that required heat and elevation.On-site findings-during an onsite visit, no irregularities were observed during the visual inspection or on the device logs.The asm rate accuracy testing found the device within specification (2.75% error).Received a copy of a medwatch which states, "free flow/ overinfusion fda safety report id# (b) (4)".Received a copy of a medwatch which states, "suspected free flow event fda safety report id # (b)(4)".

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Type of Device: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: mustafa omar ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 9173053
• MDR Text Key: 162027779
• Report Number: 9616066-2019-02861
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• UDI-Public: 10885403227998
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 69