MAUDE Adverse Event Report: B. BRAUN DOMINICAN REPUBLIC INC. EXTENSION SET; SET, ADMINISTRATION, INTRA

Catalog Number	490238
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	07/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although it was confirmed that the sample and lot number are not available for further evaluation, the investigation results are still ongoing at this time.It should be noted that although the batch number was reported as unknown, retain samples for the following batch number have been requested to be pulled for testing: batch number: 0061609578, product date: 03/08/2018, expiry date: 02/28/2021.Batch number: 0061594565, product date: 11/29/2017, expiry date: 10/31/2020.Batch number: 0061542994, product date: 01/11/2017, expiry date: 12/11/2019.Batch number: 0061502696, product date: 06/01/2016, expiry date: 05/31/2019.Batch number: 0061511068, product date: 07/01/2016, expiry date: 06/30/2019.Batch number: 00vl534252, product date: 11/10/2016, expiry date: 10/10/2019.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: it was reported that, the patient has had valve replacement in the past.In november the patient refused valve surgery.The patient continued to have swelling and respiratory distress.The patient then agreed to have valve surgery.The patient came to the hospital as transfer due to increased swelling in legs.The patient arrived from the or, with chest open, sealed with ioban and esmark, on a multi-pressors.Patient had avr and ascending aortic root repair.The patient was in hospital a few days before surgery.Uneventful or.Patient maintained blood pressure in the or during last hour and a half.The patient was then transferred to bed from or table, then brought out to open heart recovery.Within a few minutes of arriving to the icu nurse noticed 250 cc of blood was dumped into chest tube.Team then concerned with bleeding, gave bolus of normal saline, albumin and epi; however, blood pressure continued to drop.The patient was prepped to have open chest at bedside and noticed that the sheets were wet and dripping off side of bed.Christmas tree leaking at one connection point, the center of christmas tree was leaking.Internal cardiac message performed due to asystole when chest was opened and coded during 1.5- 2 hrs, before the patient could maintain his own blood pressure and heart rate.Patient had cardiac arrest possibly related to leaking ext set.Medications being infused were: epi, levophed, ns, vasopressin, milranone.Patients condition currently is minimal neuro response and anoxic brain injury.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample was returned for evaluation in connection with this incident.Retain samples were pulled and tested for the reported possible lot numbers.Based on the evaluation results, all retain samples were functionally tested per specifications.The retain samples were tested for occlusion and leakage.No defects were noted during testing.Further investigation of the complaint is not possible without the actual sample to evaluate.If a sample and/or any additional information becomes available, the complaint will be reopened.Furthermore, a review of the discrepancy management system (dsms) database was performed for the reported lot numbers revealed no abnormalities or non conformances noted during in process or final product inspection.Also, a review of the batch history records was performed and no non-conformances or deviations were noted.While we are unable to confirm the specific nature of the reported defect, all available information regarding this occurrence has been forwarded to our material review broad (mrb) business unit leaders and all personnel involved in the manufacturing and inspection of this product in order to heighten awareness.We will maintain this report for future reference, and continue to monitor other reports for similar occurrences.

• Brand Name: EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN DOMINICAN REPUBLIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, ; DR
• MDR Report Key: 7781757
• Report Number: 9614279-2018-00131
• Device Sequence Number: 16441183
• Product Code: FPA
• UDI-Device Identifier: 04046964716409
• UDI-Public: 04046964716409
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K943770
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 490238
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 08/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR