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

Catalog Number	363032
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/17/2019
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: tubing was found to be leaking during priming.The source of the leaking was unable to be determined.The leakage occurred during the priming of a hazardous medication.No injury reported.
Additional Manufacturer Narrative
This report has been identified as (b)(4).It should be noted that b.Braun medical inc.Is issuing a voluntary medical device recall removal for lot number 0061641410 of infusomat space volumetric infusion pump administration sets (product number 363032).This lot was distributed between november 23, 2018 and march 20, 2019, and has an expiration date of august 31, 2022.B.Braun medical inc.Has identified through complaints the potential of the infusion pump administration set to leak and/or disconnect at the bonded joint between the tubing and injection site (y-site).
Additional Manufacturer Narrative
No samples were returned for evaluation.Three (3) pictures were provided by the end customer.Visual inspecton of the photos could not confirm the source of the reported leakage.Although the defect was not able to be confirmed from the photos, previous samples from the same lot have confirmed the defect associated with this issue.In order to address the issue of leakage disconnection at the bonded joints between the tubing and safeline injection sites, b.Braun has initiated a corrective action/preventative action capa 2019-005-dr which provides for root cause analysis and corrective action.Review of the discrepancy management system (dsms) database performed for the reported lot number revealed no abnormalities or non-conformances noted during in process or final product inspection.

• Brand Name: INFUSOMAT®
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown 18109
• MDR Report Key: 8546997
• Report Number: 9614279-2019-00065
• Device Sequence Number: 19265178
• Product Code: FPA
• UDI-Device Identifier: 04046964294297
• UDI-Public: 04046964294297
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2019

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: 08/31/2022
• Device Catalogue Number: 363032
• Device Lot Number: 0061641410
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 04/09/2019; 04/09/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 06/14/2019; 07/17/2019
• Patient Sequence Number: 1