MAUDE Adverse Event Report: OUTLOOK®; SET, ADMINISTRATION, INTRA

Catalog Number 354214

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hypoglycemia (1912)

Event Type  Injury  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Event Description

Hold for review (kp) as reported by the user facility: it was reported that the set leaked at the cassette.Medication infusing: tpn with glucose.Reported injury: hypoglycemia - glucose 21 - received 2 boluses of d10 for treatment.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).No sample was provided for further evaluation.As a result of this issue, b.Braun has initiated a voluntary medical device correction for multiple batches of the outlook® pump sets including the batch identified from this complaint.Review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: OUTLOOK®
• Type of Device: SET, ADMINISTRATION, INTRA
• MDR Report Key: 12277290
• MDR Text Key: 265058781
• Report Number: 2523676-2021-00239
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 0061777798
• UDI-Public: 0061777798
• Combination Product (y/n): N
• PMA/PMN Number: K942988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 354214
• Device Lot Number: 0061777798
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 4 DA