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

Model Number	2120-0500
Medical Device Problem Codes	Leak/Splash (1354); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2019
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
It was reported that after 5 mins of initiating gemcitabine (1800mg/100ml) programmed at a rate of 200ml/hr.The device alarmed for ail.The rn removed the tubing out of the device to check for air in the line, rubbed fingers down the tubing however when stretching the tubing to insert back into device, the tubing disconnected from silicone segment and splashed chemo onto the rn.Although there was no patient harm, the rn was sprayed with chemo on her arms, face, hands, chest, and leg and was seen in the emergency department.It was later reported that there was no required medical interventions and the rn was released for immediate return to work however the rn does report small opened area on face and finger where chemo was exposed to skin.
Additional Manufacturer Narrative
Additional medwatch information provided.Correction on initial report: device identification (lot#).Additional information provided: device identification & device manufacture date.
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report from the fda which states, "while helping another nurse with an iv pump that kept beeping "air in line", the nurse took the tubing out of the pump and ran her fingers down the tubing connections the tubing became disconnected from the mainline squirting chemotherapy on the nurse's arms, hands, face, chest, and leg.".
Additional Manufacturer Narrative
The customer¿s report that the tubing separated and leaked was confirmed.The set was visually inspected for kinks, holes/tears in the tubing or damages to the components.Visual inspection of the set noted the retainer ring on the engagement of the silicone segment to the upper fitment component was not present.And the lower fitment component was deformed due to one side being slightly lifted and the release lever slightly angled towards the opposite lifted side.Examination under magnification of the silicone segment end observed evidence of a retainer ring indentation which does not look to be misaligned along the tubing, indicating that it had been properly assembled onto the set.Dimensional analysis of the upper fitment measured to be within specification.Slight tugging of the rest of the set¿s engagements observed no separation.The cause of the leak was due to the separation.The root cause of the customer¿s report was not identified.
Event or Problem Description
It was reported that after (5) minutes of initiating gemcitabine (1800mg/100ml) programmed at a rate of 200ml/hr.The device alarmed for ail.The rn removed the tubing out of the device to check for air in the line, rubbed fingers down the tubing however when stretching the tubing to insert back into device, the tubing disconnected from silicone segment and splashed chemo onto the rn.Although there was no patient harm, the rn was sprayed with chemo on her arms, face, hands, chest, and leg and was seen in the emergency department.It was later reported that there was no required medical interventions and the rn was released for immediate return to work however the rn does report small opened area on face and finger where chemo was exposed to skin.Customer advocacy received a copy of the customer's medwatch report from the fda which states, "while helping another nurse with an iv pump that kept beeping "air in line", the nurse took the tubing out of the pump and ran her fingers down the tubing connections the tubing became disconnected from the mainline squirting chemotherapy on the nurse's arms, hands, face, chest, and leg.".

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9304738
• Report Number: 9616066-2019-03210
• Device Sequence Number: 16693282
• Product Code: FPA
• UDI-Device Identifier: 07613203012690
• UDI-Public: 7613203012690
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• 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): 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/15/2022
• Device Model Number: 2120-0500
• Device Catalogue Number: 2120-0500
• Device Lot Number: 19086108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 12/09/2019; 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8100, 8015, THERAPY DATE (B)(6) 2019.; BAXTER IV BAG.; 8100,8015, THERAPY DATE (B)(6) 2019
• Patient Age: 67 YR
• Patient Weight: 68