MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T MACHINE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number UNKNOWN- 2008T MACHINE

Device Problem No Audible Alarm (1019)

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

Event Date 06/28/2022

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 reported that an internal dialyzer blood leak occurred at the start of a patient¿s hemodialysis treatment.It was reported that the blood was observed in the dialysis compartment and outside the membranes of the arterial head.The machine, a fresenius 2008t, did not alarm with a blood leak alert.Blood leak test strips were not used as blood was visually noted with the hansen lines.No further damage and/or defects were noted.Fresenius bloodlines were being utilized for the treatment and the patient¿s blood was not returned.The estimated blood loss (ebl) was reportedly 200 ml.It was confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient was able to complete treatment on a different machine after re-setting up supplies.The dialyzer was reported to be discarded and no longer available for manufacturer evaluation.

Manufacturer Narrative

Upon review of the available information, it was determined that the event reported in mfr 2937457-2022-01252 was related to a machine alarm issue.Upon additional information received, it was determined the machine alarmed appropriately and is not a reportable event.There was no serious injury, adverse event, or reportable malfunction.There will be no further updates on 2937457-2022-01252.

Event Description

A user facility reported that an internal dialyzer blood leak occurred at the start of a patient¿s hemodialysis treatment.It was reported that the blood was observed in the dialysis compartment and outside the membranes of the arterial head.The machine, a fresenius 2008t, did alarm appropriately with a blood leak alert.Blood leak test strips were not used as blood was visually noted with the hansen lines.No further damage and/or defects were noted.Fresenius bloodlines were being utilized for the treatment and the patient¿s blood was not returned.The estimated blood loss (ebl) was reportedly 200 ml.It was confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient was able to complete treatment on a different machine after re-setting up supplies.The dialyzer was reported to be discarded and no longer available for manufacturer evaluation.

• Brand Name: 2008T MACHINE
• 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: 15117774
• MDR Text Key: 304549210
• Report Number: 0002937457-2022-01252
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN- 2008T MACHINE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 07/27/2022
• 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
• Treatment: FRESENIUS 180NRE DIALYZER; FRESENIUS 180NRE DIALYZER; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 105 KG