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

Model Number	2420-0007
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2019
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.Although requested, it is the customer's policy to not provide patient information.
Event or Problem Description
It was reported that iv antibiotic piperacillin-tazobactam 3.375 grams in 55ml minibag was programmed to infuse at a rate of 18.3ml/hr through iv infusion pump.It was noted that the medication infused after 30 minutes instead of 3 hours.The event occurred in intensive care unit (icu).There was no patient harm.It was noted on a non-bd investigation, through review of device logs and discussions with clinical staff, that the event appears to be due to a backflow check valve failure.
Additional Manufacturer Narrative
Additional information provided: concomitant medical products & medical products & therapy dates.Correction on initial report: device identification.The customer¿s report of backflow check valve failure as the secondary infusion was confirmed.The primary and secondary set were visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components visual inspection of the set noted no damage or any anomalies.The check valves were visually inspected under magnification and both check valves were assembled in the set correctly, and the silicone membrane was centered.Functional testing resulted in fluid and air bubbles going into the primary bag on one of the two primary sets.Fluid was also noted to have gone past the check valve indicating a faulty check valve.No backflow was observed.Disassembly of the check valve found that the check valve disc was being pinched within the housing.The root cause of the customer¿s report of secondary back flowed into primary bag was caused by the check valve disc being pinched which is a supplier-related issue.A pinch disc would lead to a failure of the check valve.
Event or Problem Description
It was reported that the iv antibiotic piperacillin-tazobactam 3.375 grams in 55ml mini-bag, was programmed to infuse at a rate of 18.3ml/hr through the iv infusion pump.It was noted that the medication infused after (30) minutes instead of (3) hours.The event occurred in the intensive care unit (icu).There was no patient harm.It was noted on a non-bd investigation, through review of device logs and discussions with clinical staff, the event appears to be due to a backflow check valve failure.

• 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: 9145220
• Report Number: 9616066-2019-02779
• Device Sequence Number: 14162577
• Product Code: FPA
• UDI-Device Identifier: 10885403219870
• UDI-Public: 10885403219870
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2019

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: 2420-0007
• Device Catalogue Number: 2420-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 12/20/2019
• 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)11448964,2420-0007.; (2)8100,8015,SEC TUBING, TD 8/15/19.