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

Model Number PRI TUBING

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

Patient Problem Death (1802)

Event Date 09/10/2019

Event Type  Death  

Manufacturer Narrative

The customer¿s report of separated and leaked from the blue safety clamp was confirmed.Received from the customer was one partial primary set that was not able to be identified.The received partial set consisted of the tubing and components from the lower fitment and below.Visual inspection of the partial set found the set was received with a small portion of the silicone pump segment attached to the lower fitment.The ring retainer was still attached to the lower fitment.Inspection of the tear under a lab microscope observed the tear to be jagged.No tool marks were observed.No crush marks were observed on the lower fitment.No functional testing could be performed due to the tear in the silicone pump segment and the obvious leaking that would occur.Functional testing of the new unopened primary sets did not observe or replicate any leaks or tear damage.The source of the leak was due tear damage in the silicone pump segment near the upper fitment.The root cause of the tear damage could not be determined.Note: the customer sent a partial tubing set that was not able to be identified, however, the customer also sent one unused/unopened sample of tubing set material number 2420-0007, lot number 19023002 and one unused/unopened sample of tubing set material number 2420-0007, lot number 18073054.Section a.Demographics were requested, however not provided.The customer stated that the patient was an adult patient.

Event Description

It was reported that during a code blue on a unit, the tubing set was obtained from the code cart, attached to 1 liter normal saline, primed and inserted into a pressure bag.When the nurse inflated the pressure bag, the tubing set separated and leaked from the blue safety clamp.Although the customer stated that there was a delay in treatment and the adult patient expired, the customer further stated that the patient's death was not a result of the defective tubing set.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: sylvia ventura ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 9177022
• MDR Text Key: 161917454
• Report Number: 9616066-2019-02828
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRI TUBING
• Device Catalogue Number: PRI TUBING
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PRESSURE BAG, THERAPY DATE (B)(6) 2019
• Patient Outcome(s): Death