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

Model Number	10425228
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 1000ml baxter bag, lot #: y303347, exp oct 20, plasma-lyte a injection ph 7.4; therapy date (b)(6) 2019.The customer¿s report that the tubing became detached during an infusion was not confirmed or replicated.Functional testing did not replicate any detachments (disconnects) at any engagement along the tubing set.Pressure testing also found no abnormalities in the set.The root cause of the customer¿s experience was not identified.
Event or Problem Description
It was reported that during an infusion, the patient was critical and pressors were being run in the iv.At some point, the tubing became detached and fluid ran onto the floor.It is unknown how much medication the patient did receive.The vital signs remained the same.New tubing and medication was started.There was no patient harm.

• Brand Name: ALARIS GRAVITY SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9140020
• Report Number: 9616066-2019-02759
• Device Sequence Number: 14214580
• Product Code: FPA
• UDI-Device Identifier: 10885403234248
• UDI-Public: 10885403234248
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2019

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: 10425228
• Device Catalogue Number: 10425228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1