MAUDE Adverse Event Report: CAREFUSION AS LVP 20D DEHP 2SS 0.2M CV; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2430-0500
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that as lvp 20d dehp 2ss 0.2m cv tubing had a hole and leaked.The following information was provided by the initial reporter: material #: 2430-0500 batch #: unknown.It was reported a hole in silicone part that is inserted into the pump and leakage."i have a set that has a hole in the silicone part that is inserted inside the pump.The tubing was hung at the end of the day shift on 6/14 and discovered to be leaking (tpn dripping onto floor) during the night that night".
Event or Problem Description
It was reported that as lvp 20d dehp 2ss 0.2m cv tubing had a hole and leaked.The following information was provided by the initial reporter: material #: 2430-0500 batch #: unknown.It was reported a hole in silicone part that is inserted into the pump and leakage."i have a set that has a hole in the silicone part that is inserted inside the pump.The tubing was hung at the end of the day shift on (b)(6) of 2014 and discovered to be leaking (tpn dripping onto floor) during the night that night".
Additional Manufacturer Narrative
The customer reported ¿a hole in silicone part that is inserted into the pump and leakage¿.Received from the customer was one used primary set model 2430-0500, lot unknown.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.A small tear approximately 0.0405 inches long was observed in the silicone tubing (p/n (b)(4), just above the lower fitment (p/n (b)(4), retainer ring (p/n (b)(4).No gouge/crush marks were observed on the lower fitment.Yellowish/red liquid was observed in the set¿s drip chamber and tubing.No other abnormalities were observed with the set.Although damage was observed, functional testing was performed by filling a lab iv bag with blue-dyed water and attaching the returned used disposable set allowing fluid to flow through the set via gravity.Blue-dyed water was observed to be dripping out of the location of the tear in the silicone segment tubing.Equipment used (visual inspection and measurement performed on (b)(6) 2020.Calipers, eq02784, calibration due date: (b)(6) 20.Dino lite microscope, eq106199, ncr.Optical ram-cnc, eq08204, calibration due date: (b)(6) 21.The device history record for primary set model 2204-0007, lot unknown could not be conducted because the lot information was not provided.The leaking was determined to be due to a tear in the silicone tubing just above the lower fitment retainer ring.The root cause of the tear could not be definitively determined.

• Brand Name: AS LVP 20D DEHP 2SS 0.2M CV
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10237953
• Report Number: 9616066-2020-02019
• Device Sequence Number: 2433215
• Product Code: FPA
• UDI-Device Identifier: 07613203011396
• UDI-Public: 7613203011396
• Combination Product (Y/N): N
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2020

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: Other
• Device Model Number: 2430-0500
• Device Catalogue Number: 2430-0500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 08/31/2020
• 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: Other