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

Model Number 2420-0007

Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2019

Event Type  malfunction  

Manufacturer Narrative

The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.Race: caucasian.

Event Description

It was reported that iv lasix was infusing at 10ml/hr through primary set when a bubble formed in the pump segment of the iv set, just below the upper fitment.The bubble burst.There was no patient harm.

Manufacturer Narrative

The customer¿s report of a bubble formed in the pump segment of the iv set, just below the upper fitment was confirmed.The set was inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection of the set noted discoloration and was weakened just below the upper fitment.It was also observed that the silicone segment and retainer ring had separated from the upper fitment and were reattached to the fitment but not fully reseated.Clear liquid was observed inside the set¿s tubing and drip chamber with no other abnormalities observed.The photo provided by the customer shows that a bubble/balloon occurred at the customer site.Functional testing resulted in no ballooning/bulging.The silicone segment was analyzed and the walls were found to be concentric.The root cause for the source of the excessive pressure is unknown.

Event Description

It was reported that iv lasix was infusing at 10ml/hr through the primary set when a "bubble" formed in the pump segment of the iv set, just below the upper fitment.Subsequently, the "bubble" did burst.It was confirmed that there was no patient harm as a result of this event.

• 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
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 9088033
• MDR Text Key: 159357091
• Report Number: 9616066-2019-02640
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 7613203021012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Age: 73 YR
• Patient Weight: 98