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

Model Number 2420-0007

Device Problems Stretched (1601); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 01/27/2020

Event Type  malfunction  

Manufacturer Narrative

Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.

Event Description

It was reported from the medical icu that during infusing of milrinone 20mg/100ml at rate of 9.5ml/hr.A new bag was hung at 0545, a bubble/bulge was noted at 0630.Precedex and normal saline tko (to keep open) were infusing through a peripheral iv (piv) that was 8 hours old had been administered through this line.There was no impact to patient.

Manufacturer Narrative

Cont¿d from d.11: 100ml hospira bag lot 02-913-kl exp 1feb2021, milronine lactate injection 200 mcg (0.2 mg)/ml* in 5% dextrose injection.The customer¿s report of a bubble/ bulge was confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection observed that the set's silicone segment area near the upper fitment was found to be softer/weaker as compared to the rest of the silicone segment.Inspection of the customer provided photo confirmed the silicone balloon at the observed location.Further visual inspection of the silicone tubing confirmed that the tubing's concentricity was within specification.The root cause of the observed ballooning is caused by excess pressure within the silicone tubing segment.The root cause for the source of the excessive pressure is unknown.

Event Description

It was reported from the medical icu that during infusing of milrinone 20mg/100ml at rate of 9.5ml/hr., a new bag was hung at 0545, and a bubble/ bulge was noted at 0630.Precedex and normal saline tko (to keep open) were infusing through a peripheral iv (piv) that was (8) hours old had been administered through this line.Follow up confirmed that it is "unknown", if there was any impact to the patient associated with this event.

• 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
• MDR Report Key: 9700736
• MDR Text Key: 191985776
• Report Number: 9616066-2020-00461
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• 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: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015, 8100, THERAPY DATE (B)(6) 2020
• Patient Age: 60 YR
• Patient Weight: 71