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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 03-2722-9
Device Problem Occlusion Within Device (1423)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/14/2017
Event Type  malfunction  
Manufacturer Narrative
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 manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances identified during the manufacturing process which could be associated with the reported event.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.The lot passed all release criteria.Review of the batch production record (bpr) did not reveal a probable cause for the customer complaint.
 
Event Description
The patient care technician (pct) at the user facility reported that the arterial chamber of the combi set bloodline clotted off while a patient underwent their hemodialysis (hd) treatment.No allegation of patient adverse effects being experienced as a result of this incident.Although follow-up was requested, no additional details have been provided.
 
Event Description
A user facility¿s curse manager reported that a blood leak occurred on the combi set bloodlines approximately two (2) hours after initiation of the patient¿s hemodialysis (hd) treatment.The patient has been undergoing hd therapy three (3) times per week for five (5) years.No damage or defects were visible to the bloodline or its packaging.The patient was disconnected from the machine, the lines were put into recirculation, the transducers were replaced, saline was run through the lines, and the lines were replaced after clotting in the arterial chamber was noted.The blood within the extracorporeal circuit was not returned.The patient¿s estimated blood loss was approximately 300 milliliters (ml).The patient was re-setup with a new dialyzer and bloodline on the same machine, and then the hd therapy was continued and successfully completed without any issues.The hd machine generated a trans-membrane pressure (tmp) alarm.The patient was on heparin.No patient adverse effects were experienced and no medical intervention was required as a result of this event.The combi set bloodlines were not available to be returned to the manufacturer for evaluation.
 
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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 Key6713094
MDR Text Key80058735
Report Number8030665-2017-00442
Device Sequence Number1
Product Code FJK
UDI-Device Identifier00840861100293
UDI-Public00840861100293
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 health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/29/2020
Device Catalogue Number03-2722-9
Device Lot Number17BR01231
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Initial Date Manufacturer Received 06/14/2017
Initial Date FDA Received07/13/2017
Supplement Dates Manufacturer Received07/26/2017
Supplement Dates FDA Received08/10/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/21/2017
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 Age73 YR
Patient Weight77
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