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

Model Number	2429-0500
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
Event or Problem Description
It was reported that a patient who was transferred to their facility with a 0.9% sodium chloride 1000ml infusion, had a ballooned pumping segment at the upper fitment.The customer states that there was no harm.
Additional Manufacturer Narrative
The customer¿s report that a ballooned pumping segment formed at the upper fitment was confirmed.Visual inspection of set noted that the silicone segment tubing had a bulge (.44660 inches long,.2385 inches wide), discoloration, and was weakened just below the upper fitment.Clear liquid was observed inside the set¿s tubing and drip chambers.No other anomalies were observed.Functional testing resulted in the set flowing freely with no issues observed.No bulge/ balloon was observed in the silicone segment.The set was loaded into a lab pump module device.The primary infusion was programmed at a rate of 120ml/h and vtbi 120ml for 1 hour.No alarm or any other issues were noted by the device.No bulge/ balloon was observed in the silicone segment.The root cause of the ballooning was not identified.
Event or Problem Description
It was reported that a patient who was transferred to their facility with a 0.9% sodium chloride 1000ml infusion, had a ballooned pumping segment at the upper fitment.The customer states that there was no harm.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8860800
• Report Number: 9616066-2019-02109
• Device Sequence Number: 18958336
• Product Code: FPA
• UDI-Device Identifier: 10885403228018
• UDI-Public: 10885403228018
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2019

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
• Operator of Device: Health Professional
• Device Model Number: 2429-0500
• Device Catalogue Number: 2429-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 08/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1000ML BAXTER BAG, THERAPY DATE (B)(6) 2019; 1000ML BAXTER BAG, THERAPY DATE (B)(6) 2019
• Patient Age: 35 YR