MAUDE Adverse Event Report: GAMBRO LUNDIA AB PRISMAFLEX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 107493 (SW7.11)

Device Problem Use of Device Problem (1670)

Patient Problems Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)

Event Date 06/01/2017

Event Type  Injury  

Manufacturer Narrative

N/a.

Event Description

A patient was undergoing continuous renal replacement therapy (crrt) on a prismaflex control unit.According to received information, the involved prismaflex crrt set (type unknown) was unloaded by the nurse during ongoing treatment without having clamped the access and return blood lines or the patient's central catheter.As a consequence, an unknown volume of blood drained into the fluid bags.The use error was immediately identified and the medical staff succeeded in stabilizing the patient's blood pressure.No additional information is available.

• Brand Name: PRISMAFLEX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): GAMBRO LUNDIA AB; box 10101; lund SE-22 010; SW SE-22010
• Manufacturer (Section G): GAMBRO LUNDIA AB; box 10101; lund ; SW
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6678314
• MDR Text Key: 78764236
• Report Number: 9616026-2017-00006
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K131516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 107493 (SW7.11)
• Device Catalogue Number: 107493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention