MAUDE Adverse Event Report: GAMBRO DIALYSATOREN GMBH REVACLEAR 300; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number REVACLEAR 300

Device Problem Insufficient Information (3190)

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

Event Date 05/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

During use of a revaclear 300 dialyzer, the patient presented with symptoms of low blood pressure, flushing, anxiousness, clamminess and the patient¿s shortness of breath worsened.The symptoms appeared 15-30 minutes after the treatment started, iv (intravenous) steroids were administered and within 3 minutes the patient¿s symptoms improved.No additional information is available.

• Brand Name: REVACLEAR 300
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): GAMBRO DIALYSATOREN GMBH; holger-crafoord-str. 26; hechingen 72379 ; GM 72379
• Manufacturer (Section G): GAMBRO DIALYSATOREN GMBH; holger-crafoord-str. 26; hechingen ; GM
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6662024
• MDR Text Key: 78228790
• Report Number: 9611369-2017-00056
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/22/2017

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
• Device Operator: Health Professional
• Device Model Number: REVACLEAR 300
• Device Catalogue Number: 114745
• 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: 06/22/2017
• Distributor Facility Aware Date: 05/30/2017
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/22/2017
• Initial Date Manufacturer Received: 05/30/2017
• Initial Date FDA Received: 06/22/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR