MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. CDX W/BIBAG BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 191126

Device Problems Fluid/Blood Leak (1250); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/30/2022

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A user facility clinician reported that a patient¿s blood could not be returned after a fresenius 2008t machine alarmed with a usb device 2 error and prevented the continuation of the patient¿s hemodialysis (hd) treatment.The clinician confirmed the reported event during follow-up and stated that the event occurred approximately one hour after the initiation of the patient¿s hemodialysis (hd) treatment.The clinician stated that after the alarm occurred and treatment could not continue that the patient¿s blood began to clot and could not be returned.The patient¿s estimated blood loss (ebl) could not be provided.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was restarted on a new machine and treatment completed successfully with new supplies.The machine was pulled from service for evaluation.The machine issue was resolved after a usb drive was inserted into the machine.The machine was returned to service without reoccurrence of the reported issue.No parts were returned to the manufacturer for a physical evaluation.

Manufacturer Narrative

No parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Event Description

A user facility clinician reported that a patient¿s blood could not be returned after a fresenius 2008t machine alarmed with a usb device 2 error and prevented the continuation of the patient¿s hemodialysis (hd) treatment.The clinician confirmed the reported event during follow-up and stated that the event occurred approximately one hour after the initiation of the patient¿s hemodialysis (hd) treatment.The clinician stated that after the alarm occurred and treatment could not continue that the patient¿s blood began to clot and could not be returned.The patient¿s estimated blood loss (ebl) could not be provided.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was restarted on a new machine and treatment completed successfully with new supplies.The machine was pulled from service for evaluation.The machine issue was resolved after a usb drive was inserted into the machine.The machine was returned to service without reoccurrence of the reported issue.No parts were returned to the manufacturer for a physical evaluation.

Manufacturer Narrative

Correction: h6 (investigative finding and conclusion codes), h10 plant investigation (confirmation of reported issue) plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The manufacturer was able to determine a causal relationship between the objective evidence and the alleged event; therefore alleged event is confirmed.

Event Description

A user facility clinician reported that a patient¿s blood could not be returned after a fresenius 2008t machine alarmed with a usb device 2 error and prevented the continuation of the patient¿s hemodialysis (hd) treatment.The clinician confirmed the reported event during follow-up and stated that the event occurred approximately one hour after the initiation of the patient¿s hemodialysis (hd) treatment.The clinician stated that after the alarm occurred and treatment could not continue that the patient¿s blood began to clot and could not be returned.The patient¿s estimated blood loss (ebl) could not be provided.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was restarted on a new machine and treatment completed successfully with new supplies.The machine was pulled from service for evaluation.The machine issue was resolved after a usb drive was inserted into the machine.The machine was returned to service without reoccurrence of the reported issue.No parts were returned to the manufacturer for a physical evaluation.

• Brand Name: 2008T HD SYS. CDX W/BIBAG BLUE STAR
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 14659682
• MDR Text Key: 296865273
• Report Number: 0002937457-2022-00941
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861102099
• UDI-Public: 00840861102099
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/20/2022

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: 191126
• Device Catalogue Number: 191126
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 05/31/2022
• Initial Date FDA Received: 06/10/2022
• Supplement Dates Manufacturer Received: 07/01/2022; 07/08/2022
• Supplement Dates FDA Received: 07/08/2022; 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2019
• 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