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

Model Number 2426-0500

Device Problem Material Deformation (2976)

Patient Problem Cardiopulmonary Arrest (1765)

Event Type  Injury  

Manufacturer Narrative

Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.Additional patient information: diagnosis- coronary artery disease with chronic kidney disease.

Event Description

The customer reported that the tubing developed a balloon in the silicone segment when priming the line during a code blue.It is clarified that the customer is unsure whether the line was clamped at anytime during the priming phase.The patient had a return of spontaneous circulation and was transferred to the msicu, however, the patient outcome is unknown after the patient transfer.

Manufacturer Narrative

The customer¿s report of a balloon in the silicone segment was confirmed.Visual inspection of the set noted that the silicone segment tubing had a ballooned bulge near the lower fitment.No other anomalies were observed.Functional and pressure testing resulted in the set flowing freely and a primary infusion was run without issues., ran with no issues.No bulge/balloon was observed in the silicone segment when the device door was opened after infusion was completed.The root cause of the customer¿s report was not identified.

Event Description

It was reported that the iv tubing developed a bulge in the silicone segment just above the lower fitment, which was noted while priming the line with 0.9% sodium chloride during a 'code blue'.The customer could not confirm that the line was clamped at any time while attempting to prime the tubing.The patient's circulation eventually returned, and was transferred for observation to the msicu.Although requested, there were no further details or information of the event provided by the customer, nor was the patient's outcome provided after the transfer.

Event Description

It was reported that the iv tubing developed a bulge in the silicone segment just above the lower fitment, noted while priming the line with 0.9% sodium chloride during a 'code blue'.The customer could not confirm that the line was clamped at any time while attempting to prime the tubing.The patient's circulation eventually returned, and was transferred for observation to the msicu.Although requested, there was no further details or information of the event provided by the customer, nor was the patient's outcome provided after the transfer.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8410274
• MDR Text Key: 138765628
• Report Number: 9616066-2019-00665
• Device Sequence Number: 1
• Product Code: FPA
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2426-0500
• Device Catalogue Number: 2426-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 93 YR
• Patient Weight: 80