MAUDE Adverse Event Report: B. BRAUN DOMINICIAN REPULIC INC. INFUSOMAT®; SET, ADMINISTRATION, INTRA

Catalog Number	363010
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The device involved has not been received for evaluation and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: description of defect: the iv pump alarmed for an air bubble.The nurse removed the tubing from the pump, flicked it twice to see/move the bubble and the tubing fell apart at the connection of the white plastic 'thing' that is used to place the tubing into the pump.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used sample and several photos were provided for evaluation.Visual examination of all returned materials noted that the set was disconnected at the bonded joint between the tubing and the bottom of the pump segment.Minimal solvent residue was observed on the tubing.The inner diameter of the pump segment and outer diameter of the tubing was measured to ensure that both met specification.Incidents of this nature are attributed to operator oversight during the manual assembly of the product.Although our training procedures ensure that all of our employees are properly trained in their areas of responsibility, an oversight on the part of the operator can attribute to an incident of this nature.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: INFUSOMAT®
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN DOMINICIAN REPULIC INC.; las americas industrial park; km22 autopista las americas; DR
• MDR Report Key: 9220481
• Report Number: 9614279-2019-00194
• Device Sequence Number: 2733714
• Product Code: FPA
• UDI-Device Identifier: 04046964294174
• UDI-Public: 04046964294174
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K142036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2019

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 Catalogue Number: 363010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2019
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1