MAUDE Adverse Event Report: B.BRAUN AVITUM SAXONIA DIACAP HIPS; DIALYZER

Catalog Number SEE SECTION H10

Device Problem Device Issue (2379)

Patient Problems Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Anxiety (2328)

Event Type  Injury  

Event Description

As reported by the user facility : a total 8 events were reported related to 7 patients.Event 6: as described by the user: about 20 minutes into a therapy with diacap hips 18/diacap hips 20 the patient showed the following reactions:severe dyspnea leading to anxiety, nausea, pulmonary spasticity, concentration of the blood volume, blood pressure drop and reduced oxygen concentration.On one patient when the symptoms occurred the blood was reinfused and the dialysis was terminated.The next day the patient was treated again with the diacap.The described symptoms occurred, the dialysis was terminated again.

Manufacturer Narrative

(b)(4).Event #6.In a follow up call with the facility, the reporter would not provide information to each specific event and patient.Therefore patient traceability to dialyzer article code and lot number is not possible.Investigation associated with the reported events is ongoing at this time and a follow up report will be provided when the investigation results become available.Device not returned.

Manufacturer Narrative

(b)(4).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 ag internal report #400258383, #400258384, #400258385, #400258386 as reported by the facility a total 8 events were reported related to 7 patients.After a follow up call with the facility would not provide information to each specific event and patient.Therefore patient traceability to dialyzer article code and lot number is not possible.

Manufacturer Narrative

(b)(4).The following was reported initially ((b)(6) 2015): about 20 minutes into a therapy with diacap hips 18/diacap hips 20 the patients showed the following reactions: severe dyspnea leading to anxiety, nausea, pulmonary spasticity, concentration of the blood volume, blood pressure drop and reduced oxygen concentration.On one patient when the symptoms occurred the blood was reinfused and the dialysis was terminated.The next day the patient was treated again with the diacap.The described symptoms occurred, the dialysis was terminated again.During follow-up phone calls (2015-05-22, 2015-06-02, 2015-06-09, 2015-06-18) with the attending physician on to schedule a date for a visit on site, the following additional information became known: the therapies were terminated when the symptoms occurred.The rinsing volume of the dialyzer was 1l.The customer refused during these phone calls to give more information and did not see the necessity to discuss the cases with us.The following information was obtained from the attending physician by of our medical manger and physician during the follow-up visit with the facility 2015-06-19.All events occurred while the patients were hospitalized for different reasons (initiation of dialysis treatment, shunt problem and complications of diabetes).All patients were cardio pulmonary compromised, had no allergies, treated with convective dialysis procedures as hemofiltration and hemodiafiltration.All patients had recovered and were treated with in the following with another b.Braun avitum dialyser also having a polysulfone membrane without any further reactions.We were told by the facility that not all patients that were treated with diacap hips showed hypersensitive reactions.In at least one case the same dialyzer had been used again in patient already suspected to have hypersensitive reactions.We could not get any further information since we were not allowed by the attending physician to see any treatment or therapy records nor was she willing to discuss the cases with us and denied to give any further information.The facility reported that all dialyzers involved in the events had been discarded and therefore not available for investigation.The batch documentation of the four batches did not show any evidence of a deviation in relation to the described reaction.For all materials which are part of the product diacap hips 18 and diacap hips 20 the biocompatibility is verified.Respective biocompatibility tests were performed acc.Din en iso 10993 for the finished device.The certificates of the used raw materials with blood contact - polyurethane (pur), blood cap and sealing ring - were reviewed.There was no deviation.There is no evidence of a deviation in a raw material batch.This is confirmed by the fact, that different raw material batches were used in the complained batches.The four complained batches comprised a total of (b)(4) dialyzers, which are distributed completely and probably used already.For none of the complained batches any other complaint is known at all.From our continuous market survey we have no evidence for an accumulation of hypersensitive reactions related to the use of diacap hips dialyzers.It is known that in extracorporeal treatments hypersensitive reaction can occur.This is indicated as side effect in the instruction for use of the diacap dialysers the events had been reported as mdr because the manufacturer could not exclude a malfunction due to the missing information, not provided by the facility, and due to the fact that no complaint sample was available for investigation.Nevertheless, based on our investigation results, there is no evidence of any malfunction.

• Brand Name: DIACAP HIPS
• Type of Device: DIALYZER
• Manufacturer (Section D): B.BRAUN AVITUM SAXONIA; juri-gagarin-strasse 13; radeberg, 01454 ; GM 01454
• Manufacturer (Section G): B.BRAUN AVITUM SAXONIA; juri-gagarin-strasse 13; radeberg, 0145 4; GM 01454
• Manufacturer Contact: iris ratke ; buschberg 1; melsungen, 34212 ; GM 34212 ; 5661 71371
• MDR Report Key: 4856725
• MDR Text Key: 16994855
• Report Number: 3004201412-2015-00008
• Device Sequence Number: 1
• Product Code: FJI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K071518
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/31/2015,06/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SEE SECTION H10
• Device Lot Number: SEE SECTION H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/31/2015
• Distributor Facility Aware Date: 06/18/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/31/2015
• Date Manufacturer Received: 05/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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