MAUDE Adverse Event Report: CAREFUSION ALARIS GRAVITY SET NON-VENTED BLOOD SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 10010903

Device Problems Obstruction of Flow (2423); Deformation Due to Compressive Stress (2889); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2019

Event Type  malfunction  

Manufacturer Narrative

Unable to determine the cause of the customer's reported complaint because the set has been discarded by the customer and will not be returned.The root cause of this failure could not be identified.

Event Description

It was reported that a gravity blood set tubing appeared "kinked" out of the packaging.The clinician noted that the issue "caused extreme resistance to transfusing the blood product." the event occurred in the operating room during a resuscitation of a hemorrhaging patient.It was also reported that "during active resuscitation with blood, use of the pump chamber (i.E.The squeezing section of the tubing) resulted in an irreversible kinking of the tubing in multiple areas." the clinician stated that blood could not be administered using this tubing set, and new tubing had to be obtained.Although the issue caused a delay, there were no adverse effects to the patient.There was also no medical or surgical intervention required as a result of the event.

Event Description

It was reported that a gravity blood set tubing appeared "kinked" out of the packaging.The clinician noted that the issue "caused extreme resistance to transfusing the blood product." the event occurred in the operating room during a resuscitation of a hemorrhaging patient.It was also reported that "during active resuscitation with blood, use of the pump chamber (i.E.The squeezing section of the tubing) resulted in an irreversible kinking of the tubing in multiple areas." the clinician stated that blood could not be administered using this tubing set, and new tubing had to be obtained.Although the issue caused a delay, there were no adverse effects to the patient.There was also no medical or surgical intervention required as a result of the event.

Manufacturer Narrative

Additional information provided in section b.3.

Manufacturer Narrative

The suspect set was not received for investigation.Three associate sets were received for investigation on (b)(6) 2020.************************************************************************** the customer's report that tubing appeared kinked out of the packaging was not confirmed.The suspect set was not received for evaluation but the customer-provided photo shows a tubing kink in a portion of a used/blood-filled tubing below the quick-spike component.The customer's report the kink caused unregulated flow was not confirmed; however is likely to have occurred because the kinks confirmed in the customer photo may impede fluid flow.Visual inspection of the as-received opened and unused associate set sample 1 of 3 observed kinks after the roller clamps were disengaged.Functional testing of set 1 observed partial occlusion of the fluid flow at the kinked areas; however the kinks were able to be massaged out.Visual inspection of unopened associate sets 2 and 3 observed no kinks and the roller clamps being in the open position.The root cause was unable to be identified.

Event Description

It was reported that a gravity blood set tubing appeared "kinked" out of the packaging.The clinician noted that the issue "caused extreme resistance to transfusing the blood product." the event occurred in the operating room during a resuscitation of a hemorrhaging patient.It was also reported that; "during active resuscitation with blood, use of the pump chamber (i.E.The squeezing section of the tubing) resulted in an irreversible kinking of the tubing in multiple areas." the clinician stated that blood could not be administered using this tubing set, and new tubing had to be obtained.Although the issue caused a delay, there were no adverse effects to the patient.There was also no medical or surgical intervention required as a result of the event.

• Brand Name: ALARIS GRAVITY SET NON-VENTED BLOOD SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9587049
• MDR Text Key: 189621843
• Report Number: 9616066-2020-00143
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203020879
• UDI-Public: 7613203020879
• Combination Product (y/n): N
• PMA/PMN Number: K882302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/27/2019

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
• Device Operator: Health Professional
• Device Model Number: 10010903
• Device Catalogue Number: 10010903
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/14/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/01/2020; 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1