MAUDE Adverse Event Report: BAXTER HEALTHCARE - OPELIKA REVACLEAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urticaria (2278)

Event Type  Injury  

Manufacturer Narrative

Date of event: it was reported the event began and occurred on unknown dates then reoccurred on an unknown date in (b)(6) 2019 and (b)(6) 2019.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during an unspecified quantity of patient treatments with unknown revaclear dialyzers, the patient experienced ¿formation of hives¿.It was reported the events occurred during patient treatment.The patient was not hospitalized for the events.It was reported the patient ¿took benadryl on their own¿ when the hives were ¿all over the body¿ and resulted in ¿full recovery from each event¿.It was reported the patient ¿only experiences new hives with each (new) dialysis treatment¿.It was reported on unknown dates; the patient was given oral benadryl 50 mg for the events.It was reported for the last event; the dialyzer was flushed with 2500 ml 0.9% sodium chloride and the patient was given oral benadryl 50mg before starting treatment and halfway through treatment.Subsequently, the patient experienced hives all over the body during the last hour of treatment.The nurse reported no other treatment or medical interventions were associated with the events.No additional information is available.

Manufacturer Narrative

Additional information added to h6 h10: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: REVACLEAR
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - OPELIKA; opelika AL
• MDR Report Key: 8761041
• MDR Text Key: 150030948
• Report Number: 3006552611-2019-00070
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K130039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EXELTRA; FRESENIUS OPTIFLUX; REVACLEAR 300/400; REVACLEAR MAX; EXELTRA; FRESENIUS OPTIFLUX; REVACLEAR 300/400; REVACLEAR MAX
• Patient Outcome(s): Required Intervention