Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Problems Disconnection (1171); Fluid/Blood Leak (1250); Device Damaged by Another Device (2915)
Patient Problem Blood Loss (2597)
Event Date 02/14/2018
Event Type  malfunction  
Manufacturer Narrative
A supplemental medwatch report will be submitted upon completion of the investigation.
 
Event Description
A user facility registered nurse (rn) reported the clamps on the hemodialysis machine door broke off and the machine ate tubing, causing blood loss from patient while on dialysis.Follow-up was made with the rn, who stated was halfway into his 3 hour 45 minutes treatment when the clamps on the t machine door broke off and damaged and snapped the tubing line, causing a blood leak.Per rn it was unknown how the issue occurred and stated the patient¿s treatment was immediately stopped and the patient¿s blood was not returned.Per rn no damage to the machine, tubing line or packaging was observed prior to the event.Per rn the estimated blood loss (ebl) for the patient was approximately 100ml.Per rn the patient¿s hematocrit count was checked after the event and confirmed no patient adverse effect was experienced and no medical intervention was required as a result of these reported event.The patient was able to complete treatment with new supplies on another machine without issue.Per rn confirmed the patient dialyzed 3 times a week.Per rn the bloodline was discarded and the machine remained out of service pending repair from the biomedical engineer.
 
Event Description
A user facility registered nurse (rn) reported the clamps on the hemodialysis machine door broke off and the machine ate tubing, causing blood loss from patient while on dialysis.Follow-up was made with the rn, who stated was halfway into his 3 hour 45 minutes treatment when the clamps on the t machine door broke off and damaged and snapped the tubing line, causing a blood leak.Per rn it was unknown how the issue occurred and stated the patient¿s treatment was immediately stopped and the patient¿s blood was not returned.Per rn no damage to the machine, tubing line or packaging was observed prior to the event.Per rn the estimated blood loss (ebl) for the patient was approximately 100ml.Per rn the patient¿s hematocrit count was checked after the event and confirmed no patient adverse effect was experienced and no medical intervention was required as a result of these reported event.The patient was able to complete treatment with new supplies on another machine without issue.Per rn confirmed the patient dialyzed 3 times a week.Per rn the bloodline was discarded and the machine remained out of service pending repair from the biomedical engineer.
 
Manufacturer Narrative
Plant investigation: the device was not returned to the manufacturer for physical evaluation, and the lot number was not able to be obtained to date.Distribution records were reviewed to identify potential lots of this product shipped to the customer over the past 3 months.The entire set of lots have been sold and distributed.Batch records for the lots identified were reviewed and confirmed there were no deviations or nonconformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
MDR Report Key7286829
MDR Text Key100775441
Report Number8030665-2018-00282
Device Sequence Number1
Product Code FJK
UDI-Device Identifier00840861100309
UDI-Public00840861100309
Combination Product (y/n)N
PMA/PMN Number
K962081
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03-2742-9
Was Device Available for Evaluation? No
Device Age MO
Date Manufacturer Received03/23/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
FRESENIUS 180NRE OPTIFLUX DIALYZER; FRESENIUS 2008T HEMODIALYSIS MACHINE
Patient Age77 YR
Patient Weight71
-
-