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

Catalog Number 191126

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

Patient Problem Cardiac Arrest (1762)

Event Date 10/31/2018

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: a temporal relationship exists between hd therapy utilizing the 2008t hd sys.Cdx w/bibag blue star and the event(s) of hypotension, hypovolemia, loss of consciousness and cardiac arrest which warranted inpatient hospitalization.The definitive cause of the event(s) is unknown, as the user facility declined providing the discharge summary.However, review of the treatment data revealed a consistent downward trending bp throughout the 2:42 min of hd therapy on (b)(6) 2018.It is the impression of this reviewer the patient became hypotensive (despite a reduction in uf rate and ns boluses) due to a lack of intravascular volume, which subsequently lead to the patient¿s loss of consciousness and reported cardiac arrest.Based on the information available, the 2008t hd sys.Cdx w/bibag blue star can be disassociated from the event as there is no evidence or indication the 2008t hd sys.Cdx w/bibag blue star caused or contributed to a serious adverse event.A fresenius res performed functional compliance testing on (b)(6) 2018 and found the machine to be functioning as intended.Additionally there is no allegation or evidence of a machine malfunction or of the machine failing to perform as expected in relation to the event.Should additional information become available, the need for a clinical investigation will be re-evaluated accordingly.

Event Description

On (b)(6) 2018 a bio-medical technician (bmt) reported this (b)(6) male patient with end stage renal disease (esrd) on hemodialysis (hd) for renal replacement therapy (rrt) thrice weekly for approximately 9 months experienced a cardiac arrest while undergoing hd therapy on (b)(6) 2018.The bmt stated the patient was successfully revived, and transported to the hospital via emergency medical services (ems).During follow-up on (b)(6) 2018 the clinical manager (cm) stated the patient cardiac arrested 2 hours and 42 min into their hd treatment on (b)(6) 2018.The cm confirmed the patient was successfully resuscitated at the outpatient dialysis clinic, and was transported to the hospital suffering from disorientation.The cm declined providing additional information; however agreed to fax over the hd treatment record from (b)(6) 2018.There are two discrepancies noted in the statements made by the cm on (b)(6) 2018.The cm reported the patient remained hospitalized at the time of the call; however the faxed treatment records indicate the patient was dialyzed on (b)(6) 2018 at the outpatient dialysis clinic.Secondly, the cm stated the 2008t hd sys.Cdx w/bibag blue star was removed from service, and was awaiting a fresenius regional equipment specialist (res) evaluation.However the service confirmation record was obtained on (b)(6) 2018, and revealed the device was evaluated on (b)(6) 2018.The record indicates the 2008t hd sys.Cdx w/bibag blue star was found to be functionally compliant and performing as intended.Review of the hd treatment record shows the patient initiated treatment at 11:19, and was 7.3 kg above his edw (a weight gain of 5.6 kg since last hd treatment on (b)(6) 2018).The patient¿s vitals pre-treatment were: blood pressure (bp) = 116/78, heart rate (hr) = 76, respirations (rr) = 19 and temperature (t) = 98.2.The treatment plan was to remove 4.5 kg of fluid, over a 4.0 hour hd treatment.Although the patient¿s treatment was stable, it should be noted the patient displayed a downward trending bp since the initiation of treatment (11:19 = 113/71, 11:30 = 108/69, 12:01 = 104/65, 12:31 = 109/70, 13:07 = 100/62).At 13:34 the patient was given 100 ml of normal saline (ns) for a bp of 96/67, and the ultrafiltration (uf) was decreased to 3.0 kg.An additional 200 ml of ns was administered at 13:45 for a bp of 91/62, the uf was turned off and the md notified.The patient¿s bp at 14:00 was 92/56, and the uf was turned back on.The treatment record states the patient¿s bp at 14:16 was 88/54, and the patient cardiac arrested at 14:17 (patient¿s bp = 100/36, hr = 64).Cardiopulmonary resuscitation (cpr) measures were initiated, an automated external defibrillator (aed) was applied (no shock was advised), and the patient was given a total of 600 ml of ns between 14:17 and 14:27.Ems arrived at 14:27 and the patient was transported to the hospital at 14:30.Upon transfer the patient was conscious with a bp of 140/123, although it is unclear when the patient regained consciousness.The hospital course and discharge disposition of the patient is unknown; however an outpatient hd treatment record was provided for (b)(6) 2018 indicating the patient returned to the outpatient dialysis clinic.

Manufacturer Narrative

Plant investigation: an on-site evaluation was performed by a fresenius regional equipment specialist (res).The res performed an onsite inspection of the machine and verified the proper functioning of the machine.All pressures and settings were checked and the machine passed functional checks.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.

• 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; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 8070229
• MDR Text Key: 127210037
• Report Number: 2937457-2018-03380
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861102099
• UDI-Public: 00840861102099
• Combination Product (y/n): N
• PMA/PMN Number: K093902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 191126
• Was Device Available for Evaluation?: Yes
• Device Age: MO
• Date Manufacturer Received: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS BLOODLINES; FRESENIUS DIALYZER
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 105