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 Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

A patient was undergoing continuous renal replacement therapy (crrt) on a prismaflex control unit in continuous veno-venous hemodiafiltration (cvvhdf) mode.When attempting to return the extracorporeal blood to the patient, the prismaflex filter set allegedly unloaded before the operator was able start the blood return; the access line had been connected to a saline bag and the return line was still connected to the patient.The clinician stated there was no adverse event to the patient as a result of this alarm/issue, indicating that all clamps on the filter set had been clamped by the operator as instructed in the prismaflex graphical user interface and the operators¿ manual prior to the filter set becoming unloaded.The blood volume contained in the extracorporeal circuit could not be returned to the patient.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: 6450387
• MDR Text Key: 71418149
• Report Number: 9616026-2017-00004
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/31/2017,03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 107493 (SW7.11)
• Device Catalogue Number: 107493
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/31/2017
• Distributor Facility Aware Date: 03/05/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/31/2017
• Initial Date Manufacturer Received: 03/05/2017
• Initial Date FDA Received: 03/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2015
• 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
• Treatment: PRISMAFLEX M150 SET
• Patient Outcome(s): Other
• Patient Weight: 70