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

Model Number 10015489

Device Problem Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2017

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

The information received suggests that the pump was on hold as the user believed the iv access was blocked.The set was kinked above the port and the line was flushed to clear the occlusion at which point the pump alarmed channel error.When the user opened the door to investigate, they found that the silicone had ballooned up.From the reported information there are no indications of serious injury to the patient or user as a result of this incident.

Manufacturer Narrative

Concomitant medical products: 1000ml baxter iv infusion bag.The customer¿s report that the silicone had ballooned was confirmed.A visual inspection of the returned sample noted that the silicone tubing was slightly expanded ("ballooned") close to the upper pumping component.The sample was subjected to functional testing; the customer's report could only be confirmed if the roller clamp was closed and fluid was injected through the smartsite just below the pumping segment as this caused fluid to go back up the line and pressure started to build up due to the back check valve which caused the silicone tubing to expand.The root cause of ballooning in the silicone is caused by administering an iv push without clamping the line above the injection port creating an internal high pressure.

• 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: stephen bilello ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 6891147
• MDR Text Key: 87251366
• Report Number: 9616066-2017-01290
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10015489
• Device Catalogue Number: 10015489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2017
• 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
• Treatment: 8015,8100, THERAPY DATE 01/01/2017