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

Model Number 2420-0007

Device Problems Fluid/Blood Leak (1250); Stretched (1601)

Patient Problems Venipuncture (2129); No Consequences Or Impact To Patient (2199)

Event Date 04/27/2020

Event Type  Injury  

Manufacturer Narrative

Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.(b)(4).

Event Description

It was reported from the icu that after cleaning up the patient, the clinician went to restart the continuous renal replacement therapy dialysis machine.It was then noted that the pre-filter tubing for sodium bicarbonate 400ml solution (infusion rate set at 150ml over 4 hours) separated at the upper fitment and led to blood return and leak of fluids, which "hit the ceiling and floor".The charge nurse came in for assistance and replaced the tubing.However, the same issue occurred upon loading the new set on the same pump module.A third tubing was loaded onto the pump and it began forming a balloon at the pump segment.The rn was splashed in the face with blood and iv fluid when the tubing separated.The nursing supervisor was notified, blood specimen for (b)(6) and (b)(6) were sent the laboratory.The clinician was then notified that the (b)(6) and (b)(6) tests were both (b)(6).The clinician was further instructed to self-monitor at home for the next two weeks for any signs and symptoms of changes in temperature, cough, and shortness of breath and to notify the supervisor if the clinician had any of these symptoms.There were no adverse effect caused to the patient from this event.The rn returned to work without restrictions.

Manufacturer Narrative

As no samples were received for evaluation, no investigation was able to be performed.The root cause of two sets¿ tubing separated at the upper fitment and leaked fluids was not identified.The root cause of the third set formed a balloon at the pump segment was not identified.The device history record for primary set model: 2420-0007, lot: 20033185 was performed.The search showed a total of (b)(4) units in 1 lot were built on 19 june 2019.There were no related qn¿s (quality notifications) issued during the production build of this set for the failure mode reported for the given time frame.The device history record for primary set model: 2420-0007, lot: 20033186 was performed.The search showed a total of (b)(4) units in 1 lot were built on 19 june 2019.There were no related qn¿s (quality notifications) issued during the production build of this set for the failure mode reported for the given time frame.

Event Description

It was reported from the icu that after cleaning up the patient, the clinician went to restart the continuous renal replacement therapy dialysis machine.It was then noted that the pre-filter tubing for sodium bicarbonate 400ml solution (infusion rate set at 150ml over 4 hours) separated at the upper fitment and led to blood return and leak of fluids, which "hit the ceiling and floor".The charge nurse came in for assistance and replaced the tubing.However, the same issue occurred upon loading the new set on the same pump module.A third tubing was loaded onto the pump and it began forming a balloon at the pump segment.The rn was splashed in the face with blood and iv fluid when the tubing separated.The nursing supervisor was notified, blood specimen for human immunodeficiency virus (hiv) and hepatitis were sent the laboratory.The clinician was then notified that the hiv and hepatitis tests were both negative.The clinician was further instructed to self-monitor at home for the next two weeks for any signs and symptoms of changes in temperature, cough, and shortness of breath and to notify the supervisor if the clinician had any of these symptoms.There were no adverse effect caused to the patient from this event.The rn returned to work without restrictions.

Manufacturer Narrative

The device history record for primary set model 2420-0007 lot 20033186 was performed.The search showed a total of (b)(4) in 1 lot were built on (b)(6) 2020.There were no related qn¿s (quality notifications) issued during the production build of this set for the failure mode reported for the given time frame.

Event Description

It was reported from the icu that after cleaning up the patient, the clinician went to restart the continuous renal replacement therapy dialysis machine.It was then noted that the pre-filter tubing for sodium bicarbonate 400ml solution (infusion rate set at 150ml over 4 hours) separated at the upper fitment and led to blood return and leak of fluids, which "hit the ceiling and floor".The charge nurse came in for assistance and replaced the tubing.However, the same issue occurred upon loading the new set on the same pump module.A third tubing was loaded onto the pump and it began forming a balloon at the pump segment.The rn was splashed in the face with blood and iv fluid when the tubing separated.The nursing supervisor was notified, blood specimen for human immunodeficiency virus (hiv) and hepatitis were sent the laboratory.The clinician was then notified that the hiv and hepatitis tests were both negative.The clinician was further instructed to self-monitor at home for the next two weeks for any signs and symptoms of changes in temperature, cough, and shortness of breath and to notify the supervisor if the clinician had any of these symptoms.There were no adverse effect caused to the patient from this event.The rn returned to work without restrictions.

• 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: 10107343
• MDR Text Key: 194689697
• Report Number: 9616066-2020-01731
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2023
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: 20033186
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015,8100, TD (B)(6) 2020.
• Patient Outcome(s): Other