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

Model Number	2200-0500
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/07/2019
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
It was reported that the tubing set was "punctured" and caused normal saline to leak onto the clinicians during priming, therefore, there was no patient involvement.The customer further stated that there were no adverse effects caused to the clinicians from the event.
Additional Manufacturer Narrative
Additional information on b2.The customer¿s report that the tubing set was "punctured" was not confirmed.No damages (punctures) were observed during visual inspection and functional testing.The customer also reported that the set was leaking was confirmed.Functional testing confirmed a leak between the tubing to the drip chamber¿s outlet port due to the tubing not fully inserted into the drip chamber creating a gap between the engagement and tubing that was improperly assembled during manufacturing.No damages or other anomalies were observed during testing.The set was visually inspected for kinks, holes/tears in the tubing or damages to the components.Functional testing was performed and it was observed that droplets were leaking at the engagement between the drip chamber¿s outlet port and tubing.No other leaks were observed throughout the set.Further inspection observed insufficient solvent near the affected area of the gap.No punctures or damages were observed on the drip chamber or throughout the set.A dimensional analysis was performed on the tubing¿s inner diameter and found to be within specification(s).The root cause of the customer¿s experience was not identified due to no damages were observed during visual inspection and functional testing.The cause of the leak is a partial separation of the tubing to the drip chamber.The cause of the partial separation is a gap.The root cause of the gap is due to a combination of factors related to improper assembly due to equipment and/or operator error.
Event or Problem Description
It was reported that the tubing set was "punctured", and caused normal saline to leak onto the clinicians during priming, therefore; there was no patient involvement.The customer further stated, that there were no adverse effects caused to the clinicians from this event.
Event or Problem Description
It was reported that the tubing set was "punctured", and caused normal saline (ns) to leak onto the clinicians during priming, therefore; there was no patient involvement.The customer further stated, that there were no adverse effects caused to the clinicians from this event.
Additional Manufacturer Narrative
Correction-remove b2/congenital anomaly as it was entered in error.The customer¿s report that the tubing set was "punctured" was not confirmed.No damages (punctures) were observed during visual inspection and functional testing.The customer also reported that the set was leaking was confirmed.Functional testing confirmed a leak between the tubing to the drip chamber¿s outlet port due to the tubing not fully inserted into the drip chamber creating a gap between the engagement and tubing that was improperly assembled during manufacturing.No damages or other anomalies were observed during testing.A dimensional analysis on the tubing¿s inner diameter and was observed to be within specifications.The set was visually inspected for kinks, holes/tears in the tubing or damages to the components.Functional testing was performed by spiking the primary set to one lab iv bag filled with blue dye water and allowing fluid to flow through the set via gravity.The root cause of the customer¿s experience was not identified due to no damages were observed during visual inspection and functional testing.The cause of the leak is a partial separation of the tubing to the drip chamber.The cause of the partial separation is a gap.The root cause of the gap is due to a combination of factors related to improper assembly due to equipment and/or operator error.

• Brand Name: ALARIS PUMP MODULE ADMINSTRATION SET
• Common Device Name: SET,ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9366841
• Report Number: 9616066-2019-03441
• Device Sequence Number: 14196379
• Product Code: FPA
• UDI-Device Identifier: 07613203012638
• UDI-Public: 7613203012638
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/03/2022
• Device Model Number: 2200-0500
• Device Catalogue Number: 2200-0500
• Device Lot Number: 19065248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/23/2019
• Supplement Report FDA Received Date: 02/17/2020; 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Congenital Anomaly