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

Model Number	10933805
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Information (3190)
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.Patient age and date of birth was requested but not provided.
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report from the fda which states, "tpn was primed and ready to hang, this nurse began to place it into alaris pump when tubing disconnected at site of "pump section" where it connects to blue plastic piece.To be specific, the tubing had not even been pushed into place within the pump when it disconnected on its own.This nurse immediately roller clamped above and below breakage and held on to both pieces to insure sterility was maintained.Resource nurse was called to assist, she brought new sterile tubing and re-spiked bag while this nurse continued to ensure ends of old tubing didn't come in contact with any surfaces during the transfer.No harm was caused to patient." an incomplete date of event of (b)(6) 2019 was provided.
Additional Manufacturer Narrative
The customer¿s report of tubing disconnected at pumping segment was confirmed.Visual inspection of the set noted that the silicone segment was completely separated from the upper fitment.Further visual inspection of separated silicone segment end noted no o-ring indentations on the silicone segment.Examination under magnification noted no crush mark to the upper or lower fitment.No other anomalies were noted.Functional testing was deemed unnecessary due to a separation in the silicone tubing.Dimensional analysis of the silicone segment were measured to be within specification.The root cause of the primary set silicone segment separation was due to the set's retainer ring not being assembled onto the set during manufacturing assembly process.
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report from the fda which states, "tpn was primed and ready to hang, this nurse began to place it into alaris pump when tubing disconnected at site of "pump section" where it connects to blue plastic piece.To be specific, the tubing had not even been pushed into place within the pump when it disconnected on its own.This nurse immediately roller clamped above and below breakage and held on to both pieces to insure sterility was maintained.Resource nurse was called to assist, she brought new sterile tubing and re-spiked bag while this nurse continued to ensure ends of old tubing didn't come in contact with any surfaces during the transfer.No harm was caused to patient." an incomplete date of event of (b)(6)-2019 was provided.

• 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: 8500210
• Report Number: 9616066-2019-01000
• Device Sequence Number: 16848246
• Product Code: FPA
• UDI-Device Identifier: 07613203019088
• UDI-Public: 7613203019088
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2019

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 Model Number: 10933805
• Device Catalogue Number: 10933805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 07/08/2019
• 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: (2)CUROS ALCOHOL DISINFECTANT CAPS; NON-BD EXTENSION SET, THERAPY DATE UNK; NON-BD EXTENSION SET, THERAPY DATE UNK