MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 190610

Device Problem Inadequate Ultra Filtration (1656)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 05/26/2021

Event Type  Injury  

Manufacturer Narrative

Plant investigation: although a sample was reported to be available for manufacturer evaluation, to date no parts have been received. 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 biomedical technician (biomed) contacted fresenius technical support to report that a 2008k2 hemodialysis (hd) machine ¿removed too much weight during treatment. ¿ during the treatment the hd machine had intermittent ¿low conductivity¿ and ¿high temperature¿ alarms. Additionally, the patient reported experiencing cramping. Following treatment, it was discovered that too much fluid (1. 0 kg) was removed from the patient, and the patient was given 1500 ml of intravenous (iv) fluid replacement as a result. The treatment record was unavailable; however, it was confirmed the patient arrived at the outpatient dialysis clinic for their regularly scheduled hd treatment in stable condition, weighing (b)(6) kg. A target uf goal of 4. 5 liters was programmed and the treatment was initiated. It was reported that uf adjustments (uf pump never stopped) were made during treatment, however no specifics were provided. Despite the temperature and conductivity alarms previously mentioned, the patient¿s treatment progressed without issue until 173 of 240 minutes, when it was terminated due to cramping and ¿symptomatic¿ hypotension (specifics not provided). The patient¿s post-treatment weight (same scale) was found to be (b)(6) kg, instead of the expected 95. 5 kg. The patient was successfully treated with 1500 ml of normal saline (timeline not provided) and was sent home after treatment. No additional intervention was required. Upon inspection of the 2008k2 machine (post-treatment), it was discovered the ultrafiltration (uf) check valve was cracked, leaking, and required replacement. Furthermore, evaluation of the uf pump revealed after every few strokes ¿it delivered a stream instead of a pulse¿. The cracked and leaking check valve was replaced with a spare and discarded. The uf pump was also replaced and reported to be available for return. After the repairs were completed, the 2008k2 machine was returned to service and no further issues have been noted. Clinical investigation: a temporal relationship exists between hd therapy utilizing the 2008k2 hemodialysis system and the adverse events of cramping and hypotension, which required early termination of treatment and 1500 ml of iv fluid replacement. Upon sequestering the patient¿s 2008k2 hemodialysis system, it was discovered the uf check valve (replaced) was cracked and leaking. Additionally, the uf pump (replaced) was found to be delivering a ¿stream¿ of fluid every few strokes, instead of a pulse as expected. Muscle cramping is a common complication of hd therapy, occurring in anywhere from 33 to 86 percent of hd patients, largely due to a decreased intravascular volume. Based on the totality of the information available, the 2008k2 hemodialysis system cannot be excluded from having a possible causal and/or contributory role in the patient¿s serious adverse events. The patient was actively undergoing hd therapy when the adverse events occurred, and inspection of the check valve and uf pump revealed they were out of manufacturers specifications. A manufacturer evaluation may dissociate the uf pump from having contributed to the serious adverse events. However, the check valve was discarded and is therefore unavailable for evaluation. As such, the investigation cannot disassociate the 2008k2 hemodialysis system from the serious adverse events.

• Brand Name: 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
• 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: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 12005876
• MDR Text Key: 256450487
• Report Number: 2937457-2021-01264
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 190610
• Device Catalogue Number: 190610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 05/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 06/15/2021 Patient Sequence Number: 1

Treatment

FRESENIUS OPTIFLUX DIALYZER