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

Model Number REVACLEAR 300 APAC

Device Problem Leak/Splash (1354)

Patient Problems Headache (1880); Hemolysis (1886); High Blood Pressure/ Hypertension (1908)

Event Date 06/19/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Reportedly a patient was scheduled to perform a 4 hour dialysis treatment.The patient, who did not present with any specific symptoms prior to starting treatment, had completed 3.5 hours of dialysis with a blood flow rate of 250 ml/min when an internal dialyzer blood leak was detected in the header of the revaclear 300 dialyzer.Treatment was interrupted and the extracorporeal blood volume was not returned to the patient, who reportedly presented with headache and chest palpitations.Medical intervention consisted of blood pressure lowering medication, oxygen 3l/h and increase in set ultrafiltration (uf) volume from 1.9 to 3.2 l when restarting a new 2 hour dialysis treatment approximately 1 hour 30 minutes later.After start of this treatment, blood sampling were found to be hemolyzed and the patient was admitted to the hospital.No data related to type of intervention in connection with the hospitalization was provided, but the patient is reported to have improved as of four days after the event and was expected to be discharged from hospital within a few days.The revaclear 300 dialyzer had allegedly been primed using 600 ml of saline.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: 6716575
• MDR Text Key: 80122371
• Report Number: 9611369-2017-00059
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K130039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: REVACLEAR 300 APAC
• Device Catalogue Number: 114748
• Device Lot Number: 7-9605-H-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2017
• 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: 32 YR