MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 190766

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914)

Event Date 04/13/2020

Event Type  Death  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between hd therapy utilizing the 2008t hemodialysis system and the adverse events of hypotension and death. Despite the cn¿s statement of exclusion regarding any fresenius product(s) or device(s), the etiology of the patient¿s serious adverse events is unknown; therefore, causality cannot be established. The esrd population continues to have significantly higher mortality, and fewer expected years of life when compared to the general population. While there is no allegation or objective evidence indicating a fresenius device(s) or product(s) deficiency or malfunction caused the serious adverse events. The 2008t hemodialysis system cannot be excluded from having a possible contributory role in the patient¿s hypotension, hypertension and death, as the patient was actively undergoing hd therapy when the events occurred. Furthermore, given the lack of a death certificate, esrd death notification and discharge summary, there is insufficient evidence to disassociate the 2008t hemodialysis system from the events. The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.

Event Description

It was reported that a hemodialysis (hd) patient expired while in the hospital. Upon follow up, medical records and treatment data were received on 29/apr/2020. The treatment data indicated the patient arrived for their scheduled hd appointment on (b)(6) 2020 in stable condition. The patient was noted as having a low blood pressure (b/p) of 99/73 and was 1. 0 kg below her estimated dry weight at (b)(6) kgs. The patient¿s hd treatment began at 11:44 without issue, and the patient¿s initial bp was 86/61 (asymptomatic) with a pulse of 89 bpm. The patient¿s hypotension was noted by the hd registered nurse (hdrn) during initiation, and the treatment was started without ultrafiltration (uf) being enabled. At 11:45 the patient was given 3. 0 liters of oxygen via nasal cannula (rationale not provided), and at approximately 12:37 the patient was noticeably restless. At 12:47, the hdrn noted the patient¿s heart rate was irregular (rate not provided), and the patient kept removing the nasal cannula. The patient¿s systolic bp remained in the 80¿s until 12:58, when it climbed to 152/87 (asymptomatic). At 13:56 the patient¿s bp had climbed to 203/168, and by 14:01 the patient¿s b/p dropped to 63/41. The patient was found unresponsive, no pulse and the patient¿s oxygen saturation was at 58%. A code blue was called (patient was a full code), the uf was turned off (no indication uf was ever turned on) and the hd treatment was discontinued by 14:05. The outpatient clinic staff began cardiopulmonary resuscitative measures (cpr) at 14:05, applied an automatic external defibrillator at 14:08 and contacted emergency medical services (ems). Approximately 1050 ml of normal saline was administered to the patient during the events (including initiation); however, it is unclear if the patient¿s blood was returned. Ems arrived at 14:15 and assumed care of the patient. The patient remained unresponsive (weak pulse) upon discharge from the outpatient clinic at 14:50 and was transported to the hospital where subsequently the patient expired. The 2008t hemodialysis system was sequestered following the events, and functional compliance testing was performed the same day. Per the cn and the functional compliance report, no pre-treatment alarms were noted, and all testing fell within manufacturer specifications. Following the completion of the functional compliance testing, the 2008t hemodialysis system was approved to be returned to service. The cn reported the events were unrelated to the utilization of any fresenius product(s) or device(s).

• Brand Name: 2008T HEMODIALYSIS SYSTEM W/BIBAG
• 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: 10022159
• MDR Text Key: 189776643
• Report Number: 2937457-2020-00786
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• Is this an Adverse Event Report?: Yes

Device Operator

• Device Model Number: 190766
• Device Catalogue Number: 190766
• 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: 05/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2015
• 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: 05/04/2020 Patient Sequence Number: 1

Treatment

FRESENIUS BLOODLINES; FRESENIUS DIALYZER