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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN DOMINICAN REPUBLIC INC. BLOOD ADMINISTRATION SET SET, ADMINISTRATION, INTRA

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B. BRAUN DOMINICAN REPUBLIC INC. BLOOD ADMINISTRATION SET SET, ADMINISTRATION, INTRA Back to Search Results
Catalog Number 354218
Device Problem Fluid Leak (1250)
Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)
Event Date 09/13/2016
Event Type  Death  
Manufacturer Narrative
This report has been identified as b. Braun medical inc. (bbmi) internal report # (b)(4). A representative from bbmi is attempting to obtain the lot number and additional details from the reporting facility regarding this case. One used y-type blood set, without packaging, was received for evaluation. The set was heavily contaminated and filled with blood. There was also hardened, dry blood observed on the outer end of the top cap of the pump housing assembly. The set was subjected to leakage testing according to specification. During this testing, leakage was identified at the top cap of the blood pump housing assembly. Further sample investigation is ongoing at this time. No adverse quality trends of this nature were identified during the complaint review process for the reported product catalog number. Without the lot number, a batch record review could not be performed. The investigation into this reported event is ongoing. A follow-up report will be submitted when the results of the investigation are available.
 
Event Description
As reported by the user facility: reports a leaking blood set resulting in blood infusion interruption. The set leaked at the hand pump section during a critical blood infusion. Blood spilled out rapidly and a unit of blood was wasted. The product was removed and two other sets were attempted to be started, but had the same issue. Patient impression provided by the reporting facility: [patient] was a (b)(6) female who presented to (b)(6) hospital with evidence of gastrointestinal bleed, with initial esophagogastroduodenoscopy unremarkable. Patient, during hospital stay, however, with recurrent hematochezia and hematemesis, requiring transfusion of a total of 6 units of prbcs. Tagged red cell scan was negative for any acute hemorrhaging. Eventual cta in the end did reveal active gastric hemorrhaging. Hypertension, with hypotensive episodes during the hospital stay, likely associated with acute blood loss, requiring icu care with pressors. Acute kidney injury, likely associated with gastrointestinal bleed, which briefly improved following iv fluid hydration. Cardiopulmonary arrest with no aggressive resuscitation efforts given patient's dnr status. The patient passed at 0235 on (b)(6) 2016.
 
Manufacturer Narrative
(b)(4). One used y-type blood set, without packaging was received for evaluation. The set was subjected to leakage testing per the specification. During this testing, leakage was identified at the top cap of the blood pump housing assembly. The defect appeared to be a result of insufficient solvent in one segment of the joint and/or a combination of the cap not being seated correctly on the tubing due to irregular tubing cut or inadequate insertion depth. No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number. However, as a result of this occurrence, specifications will be updated to include irregular tubing cut characteristic during incoming inspection and also include uniform insertion of the tubing during manufacturing of the subassembly. The drawing will be modified to change the depth length and a new hand pump test will be developed for qc inspection. In addition, a formal awareness training session was conducted with all applicable personnel involved in the assembly and inspection of this product. The purpose of this training was to review the reported incident and to ensure all personnel understand and comply with the established assembly and inspection methods. Review of the discrepancy management system database and the device history records performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature. If additional pertinent information becomes available a follow-up report will be filed.
 
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Brand NameBLOOD ADMINISTRATION SET
Type of DeviceSET, ADMINISTRATION, INTRA
Manufacturer (Section D)
B. BRAUN DOMINICAN REPUBLIC INC.
las americas industrial park
km22 autopista las americas
santo domingo, dominican republic
DR
Manufacturer Contact
eric roden
las americas industrial park
km22 autopista las americas
santo domingo, dominican republic 
DR  
5491000
MDR Report Key6027303
MDR Text Key57367906
Report Number9614279-2016-00070
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K840212
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/11/2019
Device Catalogue Number354218
Device Lot Number00VL501294
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/10/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/13/2016 Patient Sequence Number: 1
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