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

Model Number	10031773
Medical Device Problem Code	Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2019
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 after priming the set with lactated ringer's the rn attached the tubing to the patient and noticed that the roller clamp was upside down.The customer confirmed that there was no patient harm however inconvenience and waste of switching the tubing and bag of lactated ringer's after iv start.
Additional Manufacturer Narrative
The customer¿s report that the roller clamp was upside down was confirmed based on visual inspection of the as-received set sample.The roller clamp component was in an incorrect orientation/upside down per the set's assembly drawing.Manual handling of the set¿s engagements observed no separation.Visual inspection of the set sample observed a roller clamp component in an incorrect orientation/upside down per the set's assembly drawing.The sample was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.No other issues were observed.The root cause was due to a misassembly of the set during the manufacturing process.
Event or Problem Description
It was reported that after priming the set with lactated ringer's, the rn attached the tubing to the patient and noticed that the roller clamp was upside down.The customer confirmed that there was no patient harm, however; there was inconvenience and waste of switching the tubing and bag of lactated ringer's after the iv start.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9331395
• Report Number: 9616066-2019-03269
• Device Sequence Number: 11323655
• Product Code: FPA
• UDI-Device Identifier: 10885403220920
• UDI-Public: 10885403220920
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 10/23/2019

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: 09/11/2022
• Device Model Number: 10031773
• Device Catalogue Number: 10031773
• Device Lot Number: 19095833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 01/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 88