MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD CUSTOM TUBING PACK PEDIATRIC; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number	BEQ-TOP 25503
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete event site name: (b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).
Event or Problem Description
It was reported that the customer noticed separation at some of the connections on their custom tubing pack.They have zip tied all the connectors.There was no patient harm, or adverse event reported.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Reference complaint # (b)(4).
Event or Problem Description
It was reported that the customer noticed separation at some of the connections on their custom tubing pack.They have zip tied all the connectors.There was no patient harm or adverse event reported.

• Brand Name: CUSTOM TUBING PACK PEDIATRIC
• Common Device Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 10855849
• Report Number: 2248146-2020-00613
• Device Sequence Number: 4283126
• Product Code: DWE
• UDI-Device Identifier: 00607567212039
• UDI-Public: 00607567212039
• Combination Product (Y/N): N
• Initial Reporter State: TX
• PMA/510(K) Number: K080592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/10/2021
• Device Model Number: BEQ-TOP 25503
• Device Catalogue Number: 709000473
• Device Lot Number: 3000111100
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1