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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. CUSTOM COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

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ERIKA DE REYNOSA, S.A. DE C.V. CUSTOM COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE Back to Search Results
Catalog Number 03-2742-9
Device Problem Disconnection (1171)
Patient Problems Cardiac Arrest (1762); Blood Loss (2597)
Event Date 08/08/2017
Event Type  malfunction  
Manufacturer Narrative
Plant investigation: the reported complaint was not confirmed as the complaint device was not available for manufacturer evaluation.As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.In addition, the dhr review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.
 
Event Description
A biomedical technician (biomed) at a user facility reported that a patient lost approximately 300 milliliters (ml) of blood during hemodialysis (hd) treatment after the catheter separated from the venous line and fistula needle.This event occurred approximately one hour and forty-five minutes into treatment.It was further stated that the fresenius 2008t hd machine did not alarm.It was reported that the patient coded during hd treatment and was transported to the hospital.The patient did not complete treatment.The facility staff does not believe that the patient code was related to the blood loss and there were no reports from the hospital that supports a relation to the blood loss.The patient was initially admitted to the hospital for observation only, however, the patient experienced a severe and required further treatment.The patient was released from the hospital after three days and has since returned to the facility for regularly scheduled hd treatment.No defect or malfunction of the fresenius products in use during the hd treatment was alleged, observed, or identified prior to, during, or following the event.No samples are available to be returned to the manufacturer for evaluation.
 
Manufacturer Narrative
Clinical investigation: although a temporal association with the adverse events of the patient¿s estimated blood loss and subsequent ¿code¿ and the 2008t machine and custom combi set exist, there is no documentation in the complaint file supporting a causal relationship between the adverse event and any fresenius product.The adverse event of blood loss was a direct result of the patient¿s dialysis venous line being pulled (dislodged) from the cvc port when the patient sneezed during hd treatment leading to the patient subsequently coding which required unknown resuscitation efforts.Additionally, there is no allegation of any machine malfunction.
 
Manufacturer Narrative
This is follow-up #2 correction: in the initial submission, it stated the following: "the patient was initially admitted to the hospital for observation only, however, the patient experienced a severe and required further treatment." the word "severe" is changed to "seizure.".
 
Event Description
The patient was initially admitted to the hospital for observation only, however, the patient experienced a seizure and required further treatment.
 
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Brand Name
CUSTOM COMBI SET
Type of Device
SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
Manufacturer (Section D)
ERIKA DE REYNOSA, S.A. DE C.V.
mike allen #1331
parque industrial reynosa
reynosa 88780
MX  88780
Manufacturer (Section G)
ERIKA DE REYNOSA, S.A. DE C.V.
mike allen #1331
parque industrial reynosa
reynosa 88780
MX   88780
Manufacturer Contact
thomas c. johnson
920 winter st.
waltham, MA 02451
7816999499
MDR Report Key6843700
MDR Text Key85131556
Report Number8030665-2017-00653
Device Sequence Number1
Product Code FJK
UDI-Device Identifier00840861100309
UDI-Public00840861100309
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K962081
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,Followup
Report Date 10/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2020
Device Catalogue Number03-2742-9
Device Lot Number17ER01243
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device Age MO
Initial Date Manufacturer Received 08/08/2017
Initial Date FDA Received09/05/2017
Supplement Dates Manufacturer Received09/12/2017
10/16/2017
Supplement Dates FDA Received10/09/2017
10/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/24/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age68 YR
Patient Weight71
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