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U.S. Department of Health and Human Services

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

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CONCORD MANUFACTURING 2008T HD SYS. CDX W/BIBAG BLUE STAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
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.
 
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Brand Name2008T HD SYS. CDX W/BIBAG BLUE STAR
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CONCORD MANUFACTURING
4040 nelson avenue
concord CA 94520
Manufacturer (Section G)
CONCORD MANUFACTURING
4040 nelson avenue
concord CA 94520
Manufacturer Contact
matthew amaral
920 winter st.
waltham, MA 02451
7816999758
MDR Report Key8070229
MDR Text Key127210037
Report Number2937457-2018-03380
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093902
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
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 Received11/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number191126
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received01/25/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/29/2018
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: 11/14/2018 Patient Sequence Number: 1
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