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

Model Number 2420-0007

Device Problem Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2020

Event Type  malfunction  

Manufacturer Narrative

The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.

Event Description

It was reported from the nurse that during a tpa infusion (with an approximate rate of infusion of 50-100 ml/hr) that the primary tubing sets bulged at the silicone segment.This occurred twice with two different tubing sets, in both cases, the tubing sets were immediately discontinued once the malfunction was detected and there was no adverse reaction to the patient related to this event.

Event Description

It was reported from the nurse that during a tpa infusion (with an approximate rate of infusion of 50-100 ml/hr) that the primary tubing sets ballooned at the silicone segment.This occurred twice with two different tubing sets, in both cases, the tubing sets were immediately discontinued once the malfunction was detected and there was no adverse reaction to the patient related to this event.

Manufacturer Narrative

The customer's report that the tubing set ballooned at the silicone segment was confirmed.Visual inspection of the area of the silicone segment, directly underneath the upper fitment, observed it to be bulged/ballooned.No other anomalies or evidence of damage were observed upon initial visual inspection.No functional testing was performed due to visual observation.The silicone tubing segment was cut and inspected under magnification; the walls were found to be concentric.Previously investigated complaints for this failure mode determined that the ballooning is caused by excess pressure within the silicone segment.The root cause for the source of the excessive pressure is unknown.

• 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: 10053943
• MDR Text Key: 190934609
• Report Number: 9616066-2020-01529
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 7613203021012
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 04/28/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/13/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100,8015,THERAPY DATE 01/01/2020