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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 Occlusion Within Device (1423)
Patient Problems Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)
Event Date 11/04/2016
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process.A supplemental medwatch will be submitted upon completion of this activity.Clinical investigation: based on the information provided, a probable association between the 2008t hemodialysis (hd) machine leak and the event of hypotension cannot be ruled out.
 
Event Description
The user facility reported that the blue dialysate tubing split allowing dialysate to leak while a patient underwent a hemodialysis treatment.The split occurred at the clamp that secures the tubing to the back of the hydraulic assembly.Reportedly, the resultant dialysate leak, caused the patient¿s blood pressure to drop quickly from 140¿s systolic to 77 systolic, and then the patient¿s blood began to clot.The user facility was not able to say whether the machine generated any audible or visual alarm at the time the event occurred.The patient was placed in a trendelenburg position and a 200ml bolus of normal saline solution was administered.The patient was also placed on oxygen via a nasal cannula.The patient¿s oxygen saturation is not known.The patient¿s estimated blood loss (ebl) was noted as being approximately 200 to 250 ml.The patient¿s blood pressure quickly returned to normal, and then the patient was re-setup on another machine to continue the hd therapy.The patient was able to complete the hd treatment without any further issues.No other medical intervention was required beyond the administration of a saline bolus.Follow-up with the area assistant technical operations manager revealed that the clamp on the dialysate inlet line at the back of the machine was found to have caused damage to the tubing which led to the dialysate leak.Simultaneously, the bloodline and dialyzer clotted as a result of no dialysate circulating through the lines.Following the event, the 2008t hemodialysis (hd) machine was removed from service for evaluation.The line and the clamp were replaced to resolve the issue.Functional testing performed by the biomed confirmed the unit was operating properly.The unit has been returned to service at the user facility without a recurrence of the event as reported.The patient continues on hemodialysis without issue.The bloodline and dialyzer are not available to be returned to the manufacturer for evaluation as both were discarded by the user facility.
 
Manufacturer Narrative
The device was not returned to the manufacturer for physical evaluation, and the lot number was not provided.Therefore, the failure mode cannot be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A manufacturing review was performed of the products shipped to the dialysis center for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius bloodline products from the reported catalog number shipped to this account within the selected time frame.A records review was performed on all lots identified.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.A review of the batch production records did not reveal a probable cause for the customer complaint.There were no non-conformances identified that relate to the reported event, and all lots met release criteria.
 
Event Description
The user facility reported that the blue dialysate tubing split allowing dialysate to leak while a patient underwent a hemodialysis treatment.The split occurred at the clamp that secures the tubing to the back of the hydraulic assembly.Reportedly, the resultant dialysate leak, caused the patient¿s blood pressure to drop quickly from 140¿s systolic to 77 systolic, and then the patient¿s blood began to clot.The user facility was not able to say whether the machine generated any audible or visual alarm at the time the event occurred.The patient was placed in a trendelenburg position and a 200ml bolus of normal saline solution was administered.The patient was also placed on oxygen via a nasal cannula.The patient¿s oxygen saturation is not known.The patient¿s estimated blood loss (ebl) was noted as being approximately 200 to 250 ml.The patient¿s blood pressure quickly returned to normal, and then the patient was re-setup on another machine to continue the hd therapy.The patient was able to complete the hd treatment without any further issues.No other medical intervention was required beyond the administration of a saline bolus.Follow-up with the area assistant technical operations manager revealed that the clamp on the dialysate inlet line at the back of the machine was found to have caused damage to the tubing which led to the dialysate leak.Simultaneously, the bloodline and dialyzer clotted as a result of no dialysate circulating through the lines.Following the event, the 2008t hemodialysis (hd) machine was removed from service for evaluation.The line and the clamp were replaced to resolve the issue.Functional testing performed by the biomed confirmed the unit was operating properly.The unit has been returned to service at the user facility without a recurrence of the event as reported.The patient continues on hemodialysis without issue.The bloodline and dialyzer are not available to be returned to the manufacturer for evaluation as both were discarded by the user facility.
 
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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 Key6145440
MDR Text Key61447501
Report Number8030665-2016-00593
Device Sequence Number1
Product Code FJK
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
Report Date 01/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03-2742-9
Other Device ID Number00840861100309
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received12/05/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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) Required Intervention;
Patient Age74 YR
Patient Weight74
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