MAUDE Adverse Event Report: B.BRAUN AVITUM AG DIALOG A +INCL. BIC; HEMODIALYSIS SYSTEM

Catalog Number 710200C

Device Problem Inadequate Ultra Filtration (1656)

Patient Problems Hypoglycemia (1912); Low Blood Pressure/ Hypotension (1914)

Event Date 03/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial information was received from the distributor in (b)(6).The machine trend file and additional information has been requested from the facility and the investigation is on-going at this time.A follow up report will be provided when the evaluation results are available.

Event Description

Event #6.As reported by the user facility in (b)(6): ultrafiltration (uf) deviation in dialysis machine dialog+ without related alarms.The ultrafiltration was higher than programmed.The patient developed general malaise, hypotension 90/40, symptoms of hypoglycemia, with cold perspiration, mucous skin paleness.

Manufacturer Narrative

Exemption number e2015012.B.Braun medical inc (importer) is submitting this report on behalf of b.Braun avitum ag (manufacturer).This report has been identified as b.Braun avitum internal report (b)(4).The analysis of the trend data records of the complained dialog+ dialysis machine showed in some cases that the dialysate outlet pressure (pda) oscillated with the movement of the balance chamber membrane.This indicated that one of the balance chamber valves did not correctly close.The investigation of the dialog+ dialysis machine by a b.Braun avitum technician on site confirmed the oscillation of the pda pressure as well as the balance deviation.In the course of this service call, all balance chamber valves were exchanged and returned for investigation.Thereafter, the dialog+ operated again as intended.The investigation of the returned balance chamber valves showed that a sliver floating in one balance chamber had slipped intermittently into the valve seat of the balance chamber valve vdabk1, preventing the valve from closing properly and thus causing the described balance deviation the sliver was identified to be of the same material as the balance chamber housing.Only a sliver of this particular size and shape was able to slip into the valve seat.A smaller sliver would have been rinsed out and a bigger sliver would not have been able to enter the valve seat.If the sliver would have been in the valve seat during the self-test of the dialog+ machine keeping the valve open, this would have been detected by the dialog+ machine and alarmed.A therapy start would then not have been possible.During the production process, all balance chamber housings are subjected first to a manual pre-deburing.Thereafter they are washed in an ultrasonic bath, dried in a compartment dryer and afterwards with compressed air.Then they are thermally deburred and washed again as described.The two cleaning procedures as well as the drying process with compressed air remove splinters which might have arisen during the production process.At the end of the production process the balance chamber housings are subjected to a 100% visual control for the absence of burrs and splinters.The subsequent assembly process of the balance chambers was reviewed.There is no process where splinters are generated, all working and storage areas are free of splinters.Therefore, it is excluded that the splinter had entered during the assembly process.Since the implementation of the production process described above, no similar case is known.Based on the investigation and the review of the manufacturing processes, the probability of occurrence of this case is assessed as being incredible.Therefore, this case is assessed as a single case and no further actions will be taken.

• Brand Name: DIALOG A +INCL. BIC
• Type of Device: HEMODIALYSIS SYSTEM
• Manufacturer (Section D): B.BRAUN AVITUM AG; schwarzenberger weg 73-79; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN AVITUM AG (REG #3002879653); schwarzenberger weg 73-79; melsungen 34212
• Manufacturer Contact: jonathan severino ; 824 10th avenue; bethlehem, PA 18018-0027 ; 4847197287
• MDR Report Key: 6569435
• MDR Text Key: 75327226
• Report Number: 3002879653-2017-00010
• Device Sequence Number: 1
• Product Code: FKJ
• Combination Product (y/n): N
• Reporter Country Code: BL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/18/2017,04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 710200C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/18/2017
• Distributor Facility Aware Date: 05/12/2017
• Device Age: 11 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/18/2017
• Date Manufacturer Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other