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

Catalog Number 114745

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

Patient Problems Rash (2033); Vomiting (2144); Loss of consciousness (2418)

Event Date 03/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

A hemodialysis (hd) patient has been experiencing multiple allergic reactions of unknown origin at various levels of severity.The patient¿s hd nurse reported that the patient¿s reactions are ¿very random,¿ occurring at various times including prior to hd treatment, during hd treatment, and post hd treatments, including reactions at the patient¿s home and on days the patient did not receive hd treatments.The reactions include the following symptoms at various times and degrees (not further specified): welts/hives/rash all over body, itching, lips and facial swelling, raspy voice, nausea and vomiting, unstable blood pressure or drop in blood pressure, convulsions, and normal saline boluses in the presence of fluid overloaded.In addition, it was reported that the patient will ¿just pass out¿, including one time when the patient fell out of their wheelchair (date unknown).The patient was hospitalized for five days related to the multiple allergic reactions.During treatment, the patient has received micera (occasionally), doxercalciferol, diphenhydramine (intravenously prior to hd treatment), acetaminophen, and midodrine prn.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: 6565459
• MDR Text Key: 75090569
• Report Number: 9611369-2017-00038
• 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: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 114745
• Device Lot Number: 6-9305-H-01
• 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: 05/12/2017
• Distributor Facility Aware Date: 04/17/2017
• Date Report to Manufacturer: 05/12/2017
• Date Manufacturer Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2016
• 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
• Patient Age: 75 YR
• Patient Weight: 117